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Appropriateness Criteria

Reference Study Type Patients/Events Study Objective(Purpose of Study) Study Results Study Quality
1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017.  Available at: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Review/Other-Dx N/A To review the National Diabetes Statistics Report. No results stated in abstract. 4
2. Duryea D, Bernard S, Flemming D, Walker E, French C. Outcomes in diabetic foot ulcer patients with isolated T2 marrow signal abnormality in the underlying bone: should the diagnosis of "osteitis" be changed to "early osteomyelitis"?. Skeletal Radiol. 46(10):1327-1333, 2017 Oct. Observational-Dx 28 patients To evaluate the variability of clinical treatment and outcomes based on reporting of diabetic foot ulcer mgnetic resonance imaging (MRI) findings of adjacent marrow T2 hyperintensity with normal T1 signal. The isolated marrow T2 signal hyperintensity was reported as "osteitis without osteomyelitis" (OW) in 12 patients, osteitis but cannot exclude early osteomyelitis" (OCEO)  in 18, and "early osteomyelitis" (EO) in 16. No statistical difference in clinical assessment was demonstrated between the OW, OCEO, and EO groups. Pathological condition was available in 15 patients within 0-7 days (mean 2.4 days) of the MRI examination, with 14 (93%) of these positive for osteomyelitis by histopathology or positive cultures. Initial diagnosis of or progression to osteomyelitis was shown in 28 patients (61%). 3
3. Trieb K.. The Charcot foot: pathophysiology, diagnosis and classification. [Review]. Bone Joint J. 98-B(9):1155-9, 2016 Sep. Review/Other-Dx N/A To raise awareness of the diagnosis of the Charcot foot (diabetic neuropathic osteoarthropathy and the differential diagnosis, erysipelas, peripheral arterial occlusive disease) and describe the ways in which the diagnosis may be made. No results stated in the abstract. 4
4. Mautone M, Naidoo P. What the radiologist needs to know about Charcot foot. [Review]. J Med Imaging Radiat Oncol. 59(4):395-402, 2015 Aug. Review/Other-Dx N/A To outline the key features of Charcot neuropathic osteoarthropathy (CN), emphasising current clinical and radiologic concepts as an aid for the practising radiologist. No results stated in abstract. 4
5. Butalia S, Palda VA, Sargeant RJ, Detsky AS, Mourad O. Does this patient with diabetes have osteomyelitis of the lower extremity? JAMA. 2008; 299(7):806-813. Review/Other-Dx 21articles reviewed To determine the accuracy of historical features, physical examination, and laboratory and basic radiographic testing. We searched for systematic reviews of MRI in the diagnosis of lower extremity osteomyelitis in patients with diabetes to compare its performance with the reference standard. The gold standard for diagnosis is bone biopsy. An ulcer area larger than 2 cm2 (positive LR, 7.2; 95% CI, 1.1-49; negative LR, 0.48; 95% CI, 0.31-0.76) and a positive “probe-to-bone” test result (summary positive LR, 6.4; 95% CI, 3.6-11; negative LR, 0.39; 95% CI, 0.20-0.76) were the best clinical findings. An erythrocyte sedimentation rate of more than 70 mm/h increases the probability of a diagnosis of osteomyelitis (summary LR, 11; 95% CI, 1.6-79). An abnormal radiograph doubles the odds of osteomyelitis (summary LR, 2.3; 95% CI, 1.6-3.3). A positive MRI result increases the likelihood of osteomyelitis (summary LR, 3.8; 95% CI, 2.5-5.8). However, a normal MRI result makes osteomyelitis much less likely (summary LR, 0.14; 95% CI, 0.08-0.26). The overall accuracy (ie, the weighted average of the sensitivity and specificity) of the MRI is 89% (95% CI, 83.0%-94.5%). An ulcer area larger than 2 cm2, a positive probe-to-bone test result, an erythrocyte sedimentation rate of more than 70 mm/h, and an abnormal radiograph result are helpful in diagnosing the presence of lower extremity osteomyelitis in patients with diabetes. A negative MRI result makes the diagnosis much less likely when all of these findings are absent. No single historical feature or physical examination reliably excludes osteomyelitis. The diagnostic utility of a combination of findings is unknown. 4
6. Markanday A.. Diagnosing diabetic foot osteomyelitis: narrative review and a suggested 2-step score-based diagnostic pathway for clinicians. [Review]. Open forum infect. dis.. 1(2):ofu060, 2014 Sep. Review/Other-Dx N/A To review the Diagnosing diabetic foot osteomyelitis. No results stated in abstract. 4
7. Dinh MT, Abad CL, Safdar N. Diagnostic accuracy of the physical examination and imaging tests for osteomyelitis underlying diabetic foot ulcers: meta-analysis. Clin Infect Dis. 2008; 47(4):519-527. Meta-analysis 68 total studies; 9 studies from literature search including 59 additional studies found from references To critically evaluate the diagnostic accuracy of clinical examination, radiographs, bone scan, WBC scan and MRI for diagnosis of osteomyelitis in diabetic patients with foot ulcers. Exposed bone or probe-to-bone test had a sensitivity of 0.60 and a specificity of 0.91. Radiography had a sensitivity of 0.54 and a specificity of 0.68. MRI had a sensitivity of 0.90 and a specificity of 0.79. Bone scan was found to have a sensitivity of 0.81 and a specificity of 0.28. Leukocyte scan was found to have a sensitivity of 0.74 and a specificity of 0.68. The diagnostic odds ratios for clinical examination, radiography, MRI, bone scan, and leukocyte scan were 49.45, 2.84, 24.36, 2.10, and 10.07, respectively. Radiography: 54% sensitive, 68% specific. MRI: 90% sensitive, 79% specific. Tc-MDP: 81% sensitive, 28% specific. In-WBC: 74% sensitive, 68% specific. The presence of exposed bone or a positive probe-to-bone test result is moderately predictive of osteomyelitis. MRI is the most accurate imaging test for diagnosis of osteomyelitis. M
8. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections.[Reprint in J Am Podiatr Med Assoc. 2013 Jan-Feb;103(1):2-7; PMID: 23328846]. Clin Infect Dis. 54(12):e132-73, 2012 Jun. Review/Other-Dx N/A To provide practice guidelines for the diagnosis and treatment of diabetic foot infections. No results stated in abstract. 4
9. Malone M, Bowling FL, Gannass A, Jude EB, Boulton AJ. Deep wound cultures correlate well with bone biopsy culture in diabetic foot osteomyelitis. Diabetes Metab Res Rev. 29(7):546-50, 2013 Oct. Observational-Dx 66 cases To determine if pathogen/s isolated via deep wound swabs correlated with bone biopsy isolates. Of 66 cases of suspected osteomyelitis in 102 joints, 34 patients had both bone biopsies and deep wound cultures over the study period. Thirty two of 34 (94%), had a history of preceding foot ulceration, and in 25 of the cases a positive probe to bone test was recorded. In a high proportion of patients, at least one similar organism was isolated from both the deep wound culture and bone biopsy procedures (25 of 34 cases, 73.5%, p<0.001). When organisms were isolated from both wound cultures and bone biopsies, the identical strain was identified in both procedures in a significant proportion of cases (16 of 25 cases, 64%, p<0.001, total sample analysis in 16 of 34 cases, 47%) 3
10. Expert Panel on Musculoskeletal Imaging:, Beaman FD, von Herrmann PF, et al. ACR Appropriateness Criteria R Suspected Osteomyelitis, Septic Arthritis, or Soft Tissue Infection (Excluding Spine and Diabetic Foot). [Review]. J. Am. Coll. Radiol.. 14(5S):S326-S337, 2017 May. Review/Other-Dx N/A Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for suspected osteomyelitis, septic arthritis, or soft tissue infection (excluding spine and diabetic foot). No results stated in abstract. 4
11. Simpfendorfer CS.. Radiologic Approach to Musculoskeletal Infections. [Review]. Infect Dis Clin North Am. 31(2):299-324, 2017 06. Review/Other-Dx N/A To review the individual imaging modalities and discusses how specific musculoskeletal infections should be approached from an imaging perspective. No results stated in abstract. 4
12. Harmer JL, Pickard J, Stinchcombe SJ. The role of diagnostic imaging in the evaluation of suspected osteomyelitis in the foot: a critical review. [Review]. FOOT. 21(3):149-53, 2011 Sep. Review/Other-Dx N/A To review the advantages and disadvantages of the main imaging techniques used for the evaluation of the foot when osteomyelitis is suspected. An evidence based algorithm for the selection of appropriate imaging techniques is suggested to aid clinicians in their decision making process. 4
13. Pineda C, Espinosa R, Pena A. Radiographic imaging in osteomyelitis: the role of plain radiography, computed tomography, ultrasonography, magnetic resonance imaging, and scintigraphy. Seminars in plastic surgery 2009;23:80-9. Review/Other-Dx N/A To review the role of plain radiography, computed tomography, ultrasonography, magnetic resonance imaging, and scintigraphy in osteomyelitis. No results listed in abstract. 4
14. Ledermann HP, Morrison WB, Schweitzer ME. Pedal abscesses in patients suspected of having pedal osteomyelitis: analysis with MR imaging. Radiology. 224(3):649-55, 2002 Sep. Observational-Dx 161 total feet; 51 women, 107 men To document the expected frequency, location, and size of pedal abscesses in patients with advanced foot infection. Abscesses were significantly more frequent in patients with osteomyelitis (n=28, 97%) (P<.001) and in feet that had been treated surgically (n=16, 33%) (P<.002). MRI revealed abscesses, predominantly in the forefoot, in 18% of patients suspected of having pedal osteomyelitis. Abscesses are significantly more frequent in patients with osteomyelitis and in feet that have been treated surgically. 3
15. Mandell JC, Khurana B, Smith JT, Czuczman GJ, Ghazikhanian V, Smith SE. Osteomyelitis of the lower extremity: pathophysiology, imaging, and classification, with an emphasis on diabetic foot infection. [Review]. EMERG. RADIOL.. 25(2):175-188, 2018 Apr. Review/Other-Dx N/A To review the pathophysiology, imaging, and classification, with an emphasis on diabetic foot infection. No results stated in abstract. 4
16. Fayad LM, Carrino JA, Fishman EK. Musculoskeletal infection: role of CT in the emergency department. Radiographics. 2007;27(6):1723-1736. Review/Other-Dx 1,196 patients: 1,122 had suspected soft-tissue infection, and 74 had suspected bone infection To examine the role of CT in the evaluation of musculoskeletal infections in the emergency department of a large inner-city hospital. CT plays an important role in the assessment of potential musculoskeletal infections in the emergency department. CT provides an analysis of compartmental anatomy, thereby helping to distinguish among the various types of musculoskeletal infection and to guide treatment options. 4
17. Chantelau EA, Grutzner G. Is the Eichenholtz classification still valid for the diabetic Charcot foot?. [Review]. Swiss Med Wkly. 144:w13948, 2014. Review/Other-Dx N/A To propose an magnetic resonance imaging (MRI)-based classification comprising two severity grades (0 and 1, according to absence/presence of cortical fractures) and two stages (active/inactive, according to presence/absence of skeletal inflammation). No results stated in abstract. 4
18. Al-Khawari HA, Al-Saeed OM, Jumaa TH, Chishti F. Evaluating diabetic foot infection with magnetic resonance imaging: Kuwait experience. Med Princ Pract. 2005; 14(3):165-172. Observational-Dx 29 diabetic patients with suspected infection To evaluate the capability of MRI to depict and characterize the changes seen in diabetic foot infections. MRI showed osteomyelitis in 14 patients, abscess in 5, cellulitis in 26, tenosynovitis in 4 and neuropathic joint in 8. 3 cases were normal. Pathological confirmations were obtained in 19 patients. MRI and histological diagnosis were in concordance in 79% of osteomyelitis cases, 100% of neuropathy cases and 100% of cellulitis cases. The sensitivity and specificity of MRI in diagnosing osteomyelitis were 100% and 63% respectively. PPV and NPV, and accuracy were 79%, 100% and 84%, respectively. MRI is a sensitive and accurate imaging modality for the evaluation of foot infections in diabetic patients and for planning proper treatment. 3
19. Rozzanigo U, Tagliani A, Vittorini E, Pacchioni R, Brivio LR, Caudana R. Role of magnetic resonance imaging in the evaluation of diabetic foot with suspected osteomyelitis. Radiol Med (Torino). 114(1):121-32, 2009 Feb. Observational-Dx 16 patients with infected ulcers To evaluate MRI in infected diabetic foot ulcers. The final diagnosis, based on clinical imaging, microbiological and histological findings, was osteomyelitis in 13/16 cases. Foot MRI allowed a correct diagnosis in 15/16 patients, with one false positive result demonstrated by CT-guided bone biopsy. MRI has high sensitivity for the detection of osteomyelitis in the diabetic foot but lower specificity related to Charcot neuropathic osteoarthropathy. 3
20. Craig JG, Amin MB, Wu K, et al. Osteomyelitis of the diabetic foot: MR imaging-pathologic correlation. Radiology. 203(3):849-55, 1997 Jun. Observational-Dx 13 patients To evaluate the efficacy of magnetic resonance (MR) imaging for the diagnosis of osteomyelitis in the diabetic foot by using anatomic and histologic studies of the resected tissue as a standard of reference. Maximum signal intensity on the T2-weighted or short inversion time inversion-recovery images of the bones was due to osteomyelitis (prospective sensitivity, 90%; specificity, 71%). Eighteen bones with increased signal intensity showed only edema of the marrow. The range of signal intensity in edema overlapped that in osteomyelitis but was lower. The use of gadopentetate dimeglumine improved delineation of soft-tissue inflammatory masses, but this contrast material was not useful in distinguishing osteomyelitis from edema. 3
21. Collins MS, Schaar MM, Wenger DE, Mandrekar JN. T1-weighted MRI characteristics of pedal osteomyelitis. AJR Am J Roentgenol. 185(2):386-93, 2005 Aug. Observational-Dx 80 feet in 80 patients To directly evaluate the reliability of primary T1 findings in surgically proven cases of pedal osteomyelitis. Decreased T1 marrow signal in a geographic medullary distribution with a confluent pattern and concordance with fat-suppressed T2- and T1-weighted postcontrast signal abnormality was present in 100% of the surgically proven cases of pedal osteomyelitis. None of the patients with decreased T1 marrow signal in a subcortical distribution or in a hazy, reticulated pattern had surgically proven osteomyelitis regardless of the fat-suppressed T2-weighted or postcontrast T1-weighted findings. 3
22. Johnson PW, Collins MS, Wenger DE. Diagnostic utility of T1-weighted MRI characteristics in evaluation of osteomyelitis of the foot. AJR Am J Roentgenol. 192(1):96-100, 2009 Jan. Observational-Dx 74 examinations of 73 patients To evaluate the diagnostic utility of specific characteristics on T1-weighted MRIs in the diagnosis of pedal osteomyelitis. Images from 74 examinations were evaluated. In 20 cases, osteomyelitis was considered present, and in 54 it was presumed absent. In 19/20 cases (95%) in which osteomyelitis was considered present, marrow T1 signal intensity was decreased, in a medullary distribution, and in a confluent pattern in all cases. In 30/54 cases (56%) in which osteomyelitis was presumed absent, T1 signal intensity was decreased, but only 5 cases (9%) had a medullary distribution and confluent pattern. 23 cases (43%) had a hazy reticulated pattern, and 2 cases (4%) had only subcortical distribution. None of the cases with a subcortical distribution or hazy reticulated pattern of abnormal signal intensity had positive results for osteomyelitis. Confluent decreased T1 marrow signal intensity in a medullary distribution was 95% sensitive in the prediction of osteomyelitis with a specificity of 91%, negative predictive value of 98%, and PPV of 79%. 3
23. Kapoor A, Page S, Lavalley M, Gale DR, Felson DT. Magnetic resonance imaging for diagnosing foot osteomyelitis: a meta-analysis. [Review] [38 refs]. Arch Intern Med. 167(2):125-32, 2007 Jan 22. Meta-analysis 16 studies To determine the diagnostic test performance of MRI for osteomyelitis of the foot and compared this performance with that of Tc- 99m bone scanning, radiography, and WBC studies. In all studies combined, the diagnostic odds ratio for MRI was 42.1 (95% CI, 14.8-119.9), and the specificity at a 90% sensitivity cut point was 82.5%. The diagnostic odds ratio did not vary greatly among subsets of studies. In studies in which a direct comparison could be made with other technologies, the diagnostic odds ratio for MRI was consistently better than that for bone scanning (7 studies; 149.9 vs 3.6), radiography (9 studies; 81.5 vs 3.3), and WBC studies (3 studies; 120.3 vs 3.4). MRI performs well in the diagnosis of osteomyelitis of the foot and ankle and can be used to rule in or rule out the diagnosis. MRI performance was markedly superior to that of Tc-99m bone scanning, radiography, and WBC studies. M
24. Schwegler B, Stumpe KD, Weishaupt D, et al. Unsuspected osteomyelitis is frequent in persistent diabetic foot ulcer and better diagnosed by MRI than by 18F-FDG PET or 99mTc-MOAB. J Intern Med. 2008; 263(1):99-106. Observational-Dx 20 diabetic patients with foot ulcers; 7+ for osteomyelitis by biopsy To assess the prevalence of clinically unsuspected osteomyelitis and to compare the value of MRI, FDG-PET and 99mTc-labelled monoclonal antigranulocyte antibody scintigraphy. Clinically unsuspected osteomyelitis is frequent in persisting foot ulcers and is a high risk factor for adverse outcome. MRI appears superior to FDG-PET and 99mTc-labelled monoclonal antigranulocyte antibody scintigraphy in detecting foot ulcer-associated osteomyelitis. MRI was positive in 6/7 patients with proven osteomyelitis, whereas FDG-PET and 99mTc-labelled monoclonal antigranulocyte antibody scintigraphy were positive only in (the same) two patients. Clinically unsuspected osteomyelitis is frequent in persisting foot ulcers and is a high risk factor for adverse outcome. MRI appears superior to FDG-PET and 99mTc-labelled monoclonal antigranulocyte antibody scintigraphy in detecting foot ulcer-associated osteomyelitis and might be the preferred imaging modality in patients with nonhealing diabetic foot ulcers. 2
25. Vesco L, Boulahdour H, Hamissa S, et al. The value of combined radionuclide and magnetic resonance imaging in the diagnosis and conservative management of minimal or localized osteomyelitis of the foot in diabetic patients. Metabolism. 1999; 48(7):922-927. Observational-Dx 24 patients To evaluate combined bone scan, labeled white cells, and MRI. Evidence of osteomyelitis was based on the presence of at least one of the following criteria: 1) Clinical bone involvement, 2) Radiological bone involvement, 3) Both positive combined radionuclide imaging and MRI, and 4) Evidence of clinical bone involvement during the follow-up period. 13 patients had osteomyelitis. 7 patients had clinical bone involvement (sensitivity, 54%), 5 patients had radiological bone involvement (sensitivity, 38%), and 10 had positive combined radionuclide imaging for osteomyelitis (sensitivity, 77%). MRI demonstrated a higher sensitivity (100%). The specificity for combined radionuclide imaging and MRI was 82%. These results lead to a new diagnostic strategy for the early detection of minimal or localized osteomyelitis to avoid amputations. MRI is most appropriate following a negative radiograph in determining whether to treat osteomyelitis, since a negative MRI result rules out osteomyelitis. Antibiotic therapy should be used in the case of a positive MRI result, but Charcot joint disease can lead to false-positive MRI results. In this case, combined radionuclide imaging should be performed. 3
26. Chantelau EA, Richter A. The acute diabetic Charcot foot managed on the basis of magnetic resonance imaging--a review of 71 cases. Swiss Med Wkly. 143:w13831, 2013 Jul 29. Observational-Dx 59 patients To assess the impact of magnetic resonance imaging (MRI), all cases of Acute Charcot foot (ACF) diagnosed by MRI between 2000 and 2012 were reviewed. Seventy-one cases (59 patients) were retrieved. Diagnosis of stage 0 (n = 27 cases) and stage 1 (n = 44 cases) was established one and two months (medians) after symptom onset, respectively. Unremarkable radiographs, that were not cross-checked by MRI (n = 13 cases), misled primary care physicians to postpone referral until five months after symptom onset, when cortical fractures had already occurred in 12 cases. Midfoot (Chopart- and Lisfranc-) lesions healed better in stage 0 versus stage 1 (69% versus 7% without deformities, p = 0.0012), while forefoot (metatarsal) lesions healed well in either stage (100% versus 75% without deformities). total contact cast (TCC)-treatment lasted four to six months 3
27. Rogers LC, Frykberg RG, Armstrong DG, et al. The Charcot foot in diabetes . Diabetes Care. 34(9):2123-9, 2011 Sep. Review/Other-Dx N/A To review the Charcot foot in diabetes No results stated in abstract. 4
28. Horowitz JD, Durham JR, Nease DB, Lukens ML, Wright JG, Smead WL. Prospective evaluation of magnetic resonance imaging in the management of acute diabetic foot infections. Ann Vasc Surg. 1993; 7(1):44-50. Observational-Dx 41 diabetic patients Prospective study to evaluate the ability of MRI to manage acute diabetic foot infections. Based on clinical outcome during the acute hospitalization period, operative findings, and/or pathologic confirmation, the PPV of MRI in defining infectious pathology in the foot was 100% in this series of 20 positive scans. The NPV of MRI was 96%. MRI is a diagnostic modality particularly well suited to evaluate acute diabetic foot infections and reliably aids in the management of acute infection to avoid exploration and debridement of uninvolved tissue. 3
29. Schweitzer ME, Morrison WB. MR imaging of the diabetic foot. [Review] [54 refs]. Radiologic Clinics of North America. 42(1):61-71, vi, 2004 Jan. Review/Other-Dx N/A To review MRI of vascular disease and diabetic pedal disease. Emphasize T1 imaging and second advantages of gadolinium enhanced imaging. Recognition of these MRI patterns is important for formulation of an appropriate treatment plan. 4
30. Leone A, Cassar-Pullicino VN, Semprini A, Tonetti L, Magarelli N, Colosimo C. Neuropathic osteoarthropathy with and without superimposed osteomyelitis in patients with a diabetic foot. [Review]. Skeletal Radiol. 45(6):735-54, 2016 Jun. Review/Other-Dx N/A To review the Neuropathic osteoarthropathy with and without superimposed osteomyelitis in patients with a diabetic foot. No results stated in abstract. 4
31. Jay PR, Michelson JD, Mizel MS, Magid D, Le T. Efficacy of three-phase bone scans in evaluating diabetic foot ulcers. Foot Ankle Int. 1999; 20(6):347-355. Observational-Dx 34 bone scans To retrospectively evaluate the utility of bone scans in determining the treatment of diabetic patients with foot ulcers. There was no significant difference in the amputation rate for patients with confirmatory, indeterminate, or nonconfirmatory bone scans for osteomyelitis (36%, 37%, and 50%, respectively) (P>0.5). Therefore, it is concluded that the ultimate treatment should be based on clinical indicators of the presence of uncontrolled infection or gangrene rather than on bone scan findings. 3
32. Schauwecker DS, Park HM, Burt RW, Mock BH, Wellman HN. Combined bone scintigraphy and indium-111 leukocyte scans in neuropathic foot disease. J Nucl Med. 29(10):1651-5, 1988 Oct. Observational-Dx 18 patients To detect and to accurately localize infection to bone and/or to the adjacent soft tissues of the feet. Among the 18 patients without osteomyelitis, eight had no accumulation of [111In]leukocytes, seven had the [111In]leukocyte activity correctly localized to the soft tissue, two had [111In]leukocyte activity mistakenly attributed to the bone, and one had [111In]leukocyte accumulation in a proven neuroma which was mistakenly attributed to bone. These three false-positive results for osteomyelitis reduced the specificity to 83%. Considering only the 27 patients with a positive [111In]leukocyte study, the combined bone scan and [111In]leukocyte study correctly localized the infection to the soft tissues or bone in 89%. 3
33. Seabold JE, Flickinger FW, Kao SC, et al. Indium-111-leukocyte/technetium-99m-MDP bone and magnetic resonance imaging: difficulty of diagnosing osteomyelitis in patients with neuropathic osteoarthropathy. J Nucl Med. 31(5):549-56, 1990 May. Observational-Dx 14 patients To evaluate the accuracy of these techniques in the detection of osteomyeitis. Five of 16 sites (31%) had false-positive 111In-WBC uptake at noninfected sites. There were four true-positive and three false-positive MR studies. All false-positives showed at least moderately abnormal findings by both techniques at sites of rapidly progressing osteoarthropathy of recent onset. In this preliminary study, both techniques appear to be sensitive for detection of osteomyelitis, and a negative study makes osteomyelitis unlikely. However, the findings of 111In-WBC/99mTc-MDP and MR images at sites of rapidly progressing, noninfected neuropathic osteoarthropathy may be indistinguishable from those of osteomyelitis. 3
34. Palestro CJ, Love C, Tronco GG, Tomas MB, Rini JN. Combined labeled leukocyte and technetium 99m sulfur colloid bone marrow imaging for diagnosing musculoskeletal infection. Radiographics. 2006;26:859-70. Review/Other-Dx N/A To review combined labeled leukocyte and Tc-99m sulfur colloid bone marrow imaging for diagnosing musculoskeletal infection. Combined WBC-marrow imaging is a very accurate technique for diagnosing osteomyelitis. 4
35. Al-Sheikh W, Sfakianakis GN, Mnaymneh W, et al. Subacute and chronic bone infections: diagnosis using In-111, Ga-67 and Tc-99m MDP bone scintigraphy, and radiography. Radiology 1985;155:501-6. Observational-Dx 21 patients To evaluate the usefulness of indium-111 white blood cell scintigraphy in the diagnosis of subacute or chronic bone infection. In-111 WBC scintigraphy showed no definite advantage over Ga-67 scintigraphy in the identification of chronic bone infection. The two tests had the same sensitivity (80%) and similar specificity (In-111 WBC 75%, Ga-67 83%; difference not significant). Bone radiography had a sensitivity of 60% and a specificity of 67%. A negative Tc-99m MDP bone scintigram ruled out infection (sensitivity 100%), but because of low specificity (25%), final evaluation required performance of Ga-67 or In-111 WBC scintigraphy. 3
36. Palestro CJ, Mehta HH, Patel M, et al. Marrow versus infection in the Charcot joint: indium-111 leukocyte and technetium-99m sulfur colloid scintigraphy. Journal of Nuclear Medicine. 39(2):346-50, 1998 Feb. Observational-Dx 17 patients To evaluate the role of combined leukocyte/marrow scintigraphy in the assessment of the neuropathic or Charcot joint. Labeled leukocyte accumulation in the uninfected Charcot joint does occur and is related, at least in part, to hematopoietically active marrow. Leukocyte/marrow scintigraphy is a reliable way to differentiate between marrow and infection as the cause of labeled leukocyte accumulation in the neuropathic joint and, in this series, was superior to both three-phase bone scintigraphy and combined leukocyte/bone scintigraphy. 3
37. Palestro CJ, Love C, Miller TT. Infection and musculoskeletal conditions: Imaging of musculoskeletal infections. [Review] [95 refs]. Baillieres Best Pract Res Clin Rheumatol. 20(6):1197-218, 2006 Dec. Review/Other-Dx N/A To review imaging of musculoskeletal infections. MRI is sensitive, provides superb anatomic detail, does not use ionizing radiation, and is rapidly completed. This technique is especially valuable for septic arthritis, spinal osteomyelitis, and diabetic foot infections. Among the radionuclide procedures, three-phase bone imaging is readily available, and very accurate in unviolated bone. Labeled leukocyte imaging should be used in cases of ‘complicating osteomyelitis’ such as prosthetic joint infections. This test is also useful in unsuspected diabetic pedal osteomyelitis and the neuropathic joint. Gallium imaging is a useful adjunct to MRI in spinal infection. FDG-PET will likely play an important role, especially in the evaluation of spinal infection. 4
38. Trevail C, Ravindranath-Reddy P, Sulkin T, Bartlett G. An evaluation of the role of nuclear medicine imaging in the diagnosis of periprosthetic infections of the hip. Clin Radiol. 71(3):211-9, 2016 Mar. Observational-Dx 235 patients To validate the role of nuclear medicine (NM) imaging in hip periprosthetic joint infection (PJI) of hip arthroplasties. There were 14 exclusions. Of the 221 remaining patients, there were 16 true positives, one false positive, 200 true negatives, and four false negatives. The algorithm used at this centre demonstrated an accuracy of 97.7% with high specificity of 99.5% and sensitivity of 80%. 3
39. Basu S, Chryssikos T, Houseni M, et al. Potential role of FDG PET in the setting of diabetic neuro-osteoarthropathy: can it differentiate uncomplicated Charcot&#39;s neuroarthropathy from osteomyelitis and soft-tissue infection?. Nucl Med Commun. 28(6):465-72, 2007 Jun. Observational-Dx 63 total patients To evaluate the use of PET in the detection of infection and differentiation from acute neuropathic osteoarthropathy in the setting of a complicated diabetic foot. Overall sensitivity and accuracy of FDG-PET in the diagnosis of Charcot’s foot was 100% and 93.8%, respectively; and for MRI were 76.9% and 75%, respectively. FDG-PET showed foci of abnormally enhanced uptake in the soft-tissue which was suggestive of inflammation in 7 cases (43.75%) which were proven pathologically to be secondary to infection. In only two of these cases the features of soft tissue infection were noted on the MRI. The results support a valuable role of FDG-PET in the setting of Charcot’s neuroarthropathy by reliably differentiating it from osteomyelitis both in general and when foot ulcer is present. 2
40. Hopfner S, Krolak C, Kessler S, et al. Preoperative imaging of Charcot neuroarthropathy in diabetic patients: comparison of ring PET, hybrid PET, and magnetic resonance imaging. Foot Ankle Int. 25(12):890-5, 2004 Dec. Observational-Dx 16 patients with type II diabetes To investigate the value of two types of PET in the preoperative evaluation of diabetic patients with Charcot foot deformities. Of 39 Charcot lesions confirmed at surgery, 37 were detected by ring PET, 30 by hybrid PET, and 31 by MRI. PET (ring or hybrid) can be used in the evaluation of patients with metal implants that would compromise the accuracy of MRI. Another advantage of PET is its ability to distinguish between inflammatory and infectious soft-tissue lesions, and between osteomyelitis and Charcot neuroarthropathy. The differentiation between Charcot neuroarthropathy and florid osteomyelitis provides the surgeon with important additional information that often is unavailable from MRI. Because it provides important additional data, ring PET may be preferable to radiography and MRI in the preoperative evaluation of patients with Charcot neuroarthropathy of the foot. Hybrid PET, because of its poorer resolution compared to ring PET, appears less suitable for routine clinical application. 2
41. Palestro CJ.. FDG-PET in musculoskeletal infections. [Review]. Semin Nucl Med. 43(5):367-76, 2013 Sep. Review/Other-Dx N/A To review role of FDG-PET in musculoskeletal infections. FDG-PET (PET/CT) is assuming an increasingly important role in the diagnostic workup of musculoskeletal infection. FDG offers advantages over conventional radionuclide techniques. 4
42. Kagna O, Srour S, Melamed E, Militianu D, Keidar Z. FDG PET/CT imaging in the diagnosis of osteomyelitis in the diabetic foot. Eur J Nucl Med Mol Imaging. 39(10):1545-50, 2012 Oct. Observational-Dx 39 patients To assess the value of Fluorodeoxyglucose F18 (FDG) PET/ computed tomography (CT) in diabetic patients with clinically suspected osteomyelitis. Osteomyelitis was correctly diagnosed in 18 and excluded in 21 sites. Of 20 lesions with focal bone FDG uptake, 2 were false-positive with no further evidence of osteomyelitis. Five sites of diffuse FDG uptake involving more than one bone on CT were correctly diagnosed as diabetic osteoarthropathy. FDG PET/CT had a sensitivity, specificity and accuracy of 100 %, 92 % and 95 % in a patient-based analysis and 100 %, 93 % and 96 % in a lesion-based analysis, respectively, for the diagnosis of osteomyelitis in the diabetic foot. 1
43. Keidar Z, Militianu D, Melamed E, Bar-Shalom R, Israel O. The diabetic foot: initial experience with 18F-FDG PET/CT. J Nucl Med. 46(3):444-9, 2005 Mar. Observational-Dx 14 diabetic patients To assess the role of PET/CT using FDG for the diagnosis of diabetic foot osteomyelitis. PET detected 14 foci of increased FDG uptake suspected as infection in 10 patients. PET/CT correctly localized 8 foci in 4 patients to bone, indicating osteomyelitis. PET/CT correctly excluded osteomyelitis in 5 foci in 5 patients, with the abnormal FDG uptake limited to infected soft tissues only. One site of mildly increased focal FDG uptake was localized by PET/CT to diabetic osteoarthropathy changes demonstrated on CT. Four patients showed no abnormally increased FDG uptake and no further evidence of an infectious process on clinical and imaging follow-up. FDG-PET can be used for diagnosis of diabetes-related infection. The precise anatomic localization of increased FDG uptake provided by PET/CT enables accurate differentiation between osteomyelitis and soft-tissue infection. 3
44. Chacko TK, Zhuang H, Nakhoda KZ, Moussavian B, Alavi A. Applications of fluorodeoxyglucose positron emission tomography in the diagnosis of infection. Nucl Med Commun. 2003;24(6):615-624. Observational-Dx 167 scans to evaluate 175 potential sites of infection To assess the accuracy of FDG-PET in diagnosing infection in a large population of patients and in a variety of clinical circumstances where the performance of conventional imaging modalities has been questioned. The overall accuracy of FDG-PET in evaluating orthopedic hardware was 96.2% for hip prosthesis, 81% for knee prosthesis, and 100% in 15 patients with other orthopedic devices. Among the patients in the sample suspected of having chronic osteomyelitis, the accuracy was 91.2%. FDG-PET was inaccurate in 3 cases of fever of unknown origin and accurate in all vascular graft and soft tissue infections. In 49 patients with a clinically apparent soft-tissue infection, FDG-PET was able to detect or exclude underlying osteomyelitis with an accuracy of 92.3%. Among the 23 patients who had recent orthopedic procedures, FDG-PET imaging was accurate in 87% of cases. 3
45. Crymes WB, Jr., Demos H, Gordon L. Detection of musculoskeletal infection with 18F-FDG PET: review of the current literature. J Nucl Med Technol. 2004;32(1):12-15. Review/Other-Dx 7 articles; 273 cases of suspected musculoskeletal infection Literature search was performed to determine the effectiveness of FDG-PET in the evaluation of musculoskeletal infection. The current literature suggests that FDG-PET is a highly accurate method to detect musculoskeletal infection. 4
46. Wang GL, Zhao K, Liu ZF, Dong MJ, Yang SY. A meta-analysis of fluorodeoxyglucose-positron emission tomography versus scintigraphy in the evaluation of suspected osteomyelitis. Nucl Med Commun. 32(12):1134-42, 2011 Dec. Meta-analysis 23 studies representing 851 examinations To perform a meta-analysis to obtain a reliable estimate of the diagnostic performance of FDG-PET, three-phase bone scintigraphy, leukocyte scintigraphy, and monoclonal antigranulocyte antibody scintigraphy in the assessment of suspected osteomyelitis and to perform pairwise comparisons of the diagnostic accuracy between these different imaging modalities. The FDG-PET had a pooled sensitivity of 0.923, specificity of 0.920, and AUC of 0.9666, whereas for bone scintigraphy, the corresponding values were 0.827, 0.446, and 0.6514, respectively, for leukocyte scintigraphy, the corresponding values were 0.742, 0.881, and 0.9139, respectively, and for monoclonal antigranulocyte antibody, the corresponding values were 0.883, 0.705, and 0.8897, respectively. The meta-analysis did not find statistically significant differences in the sensitivity, specificity, AUC, and Q* index between FDG-PET and leukocyte scintigraphy. M
47. Filippi L, Schillaci O. Usefulness of hybrid SPECT/CT in 99mTc-HMPAO-labeled leukocyte scintigraphy for bone and joint infections. J Nucl Med. 2006;47(12):1908-1913. Observational-Dx 28 patients To evaluate the usefulness of SPECT and transmission CT performed simultaneously using a hybrid imaging device for the functional anatomic mapping of bone and joint infections. (99m)Tc-HMPAO scintigraphy was true-positive for infection in 18/28 patients (for a total of 21 sites of uptake) and true-negative in 10/28 subjects. SPECT/CT provided an accurate anatomic localization of all positive foci. With regard to the final diagnosis, SPECT/CT added a significant clinical contribution in 10/28 patients (35.7%). In fact, SPECT/CT differentiated soft-tissue from bone involvement both in patients with osteomyelitis and in patients with orthopedic implants, allowed correct diagnosis of osteomyelitis in patients with structural alterations after trauma, and identified synovial infection without prosthesis involvement in patients with a knee implant. 2
48. Horger M, Eschmann SM, Pfannenberg C, et al. The value of SPET/CT in chronic osteomyelitis. Eur J Nucl Med Mol Imaging. 2003;30(12):1665-1673. Observational-Dx 27 patients To evaluate the use of a combined SPECT/CT device to improve detection and anatomical definition of inflammatory bone lesions. On a lesion-by-lesion basis 19 true positive, 1 false positive and 9 true negative findings were obtained. SPECT/CT correctly identified the location of all positive foci in the appendicular skeleton and that of a cold lesion in the axial skeleton. It also enabled differentiation between soft tissue infection, septic arthritis and osteomyelitis, as well as between cortical, corticomedullary and subperiosteal foci. Sensitivity was identical for SPECT and SPECT/CT (100%), whereas specificity was improved from 78% to 89% by the use of SPECT/CT. Combined SPECT/CT improves the accuracy of immunoscintigraphy by allowing correct differentiation between soft tissue infection and bone involvement. 3
49. Horger M, Eschmann SM, Pfannenberg C, et al. Added value of SPECT/CT in patients suspected of having bone infection: preliminary results. Arch Orthop Trauma Surg. 2007;127(3):211-221. Observational-Dx 31 patients To evaluate the contribution of SPECT/CT as an adjunct to combined three-phase bone scintigraphy (planar and SPECT) for diagnosing and localizing bone infection. Subsequently, the diagnostic performance of SPECT/CT was compared to visual fusion of SPECT with data of additional CT, X-ray, or MRI studies (SPECT + CT/X-ray/MRI). Three-phase bone scan (incl. SPECT) correctly classified 7 lesions as positive and 11 lesions as negative for osteomyelitis. 6 scans were interpreted false positive, 2 false negative, and 5 as equivocal. Rating the latter as positive for osteomyelitis, sensitivity of bone scan was (78%), specificity (50%). SPECT/CT was true positive in 7 patients, and true negative in 19. There were 2 false positive and 2 false negative findings, 1 scan was equivocal (sensitivity 78%, specificity 86%). Definition of anatomical localization of inflammatory foci was much easier by SPECT/CT due to better depiction of underlying anatomical details. SPECT + CT/X-ray/MRI yielded the highest sensitivity (100% compared to 78% of SPECT/CT), if equivocal findings (5/31 compared to 1/31 for SPECT/CT) are rated as true positive for osteomyelitis. Among radiological techniques, MRI (2 x false positive) and CT (2 x false negative) proved equal and expectedly superior to X-ray in delivering the correct diagnosis. 3
50. La Fontaine J, Bhavan K, Lam K, et al. Comparison Between Tc-99m WBC SPECT/CT and MRI for the Diagnosis of Biopsy-proven Diabetic Foot Osteomyelitis. WOUNDS. 28(8):271-8, 2016 Aug. Observational-Dx 110 patients To diagnose osteomyelitis is bone biopsy, with a positive culture and/or histopathology findings consistent with osteomyelitis. For inclusion criteria, 110 patients met the study's criteria: 52 single-photon emission computed tomography/computed tomography (SPECT/CT) patients and 58 Magnetic resonance imaging (MRI) patients. The sensitivity, specificity, positive predictive value, and negative predictive value of SPECT/CT were 89%, 35%, 74%, and 60%, respectively; the corresponding values for MRI were 87%, 37%, 74%, and 58%, respectively. There were no significant differences in accuracy of diagnosing diabetic foot osteomyelitis (DFO) between imaging techniques. 3
51. Heiba SI, Kolker D, Mocherla B, et al. The optimized evaluation of diabetic foot infection by dual isotope SPECT/CT imaging protocol. J Foot Ankle Surg. 49(6):529-36, 2010 Nov-Dec. Observational-Dx 272 patients To investigate a method that combines the imaging of multiple radiopharmaceuticals using single-photon emission computedtomography/computed tomography (SPECT/CT) fusion for an accurate diagnosis and precise localization of diabetic foot infection. Distinction between various diagnostic categories and overall osteomyelitis (OM) diagnostic accuracy in 213 patients were higher for DI than WBCS or bone scintigraphy (BS) alone, and for DI SPECT/CT than DI planar or SPECT only. Diagnostic confidence/lesion site was significantly higher for DI SPECT/CT than other comparative imaging methods. In a group of 97 patients with confirmed microbiologic/pathologic diagnosis, similar results were attained. Step 2 DI SPECT/CT performed in 67 patients further improved diagnostic accuracy/confidence. DI SPECT/CT is a highly accurate modality that considerably improves detection and discrimination of STI and OM while providing precise anatomic localization in the diabetic foot. This combined imaging technique promises to beneficially impact diabetic patient care. 2
52. Grayson ML, Gibbons GW, Balogh K, Levin E, Karchmer AW. Probing to bone in infected pedal ulcers. A clinical sign of underlying osteomyelitis in diabetic patients. JAMA. 1995; 273(9):721-723. Observational-Dx 75 patients (76 infected foot ulcers) To prospectively assess infected pedal ulcers for detectable bone by probing with a sterile, blunt, stainless steel probe. The relationship between detection of bone and the presence or absence of osteomyelitis that was defined histopathologically and/or clinically was examined. Osteomyelitis was diagnosed in 50 instances (66%) and was excluded in 26 instances. Bone was detected by probing in 33/50 ulcers with contiguous osteomyelitis; in contrast, bone was probed in 4/26 ulcers without contiguous osteomyelitis (P<.001). Bone detected on probing was visible in only 3 instances. Palpating bone on probing the pedal ulcer had a sensitivity of 66% for osteomyelitis, a specificity of 85%, a PPV of 89%, and NPV of 56%. Palpation of bone in the depths of infected pedal ulcers in patients with diabetes is strongly correlated with the presence of underlying osteomyelitis. If bone is palpated on probing, specialized roentgenographic and radionuclide tests to diagnose osteomyelitis are unnecessary. Probing for bone should be included in the initial assessment of all diabetic patients with infected pedal ulcers. 3
53. Lavery LA, Armstrong DG, Peters EJ, Lipsky BA. Probe-to-bone test for diagnosing diabetic foot osteomyelitis: reliable or relic? Diabetes Care. 2007; 30(2):270-274. Observational-Dx 1,666 consecutive diabetic individuals To assess the accuracy of the probe-to-bone test in diagnosing foot osteomyelitis in a cohort of diabetic patients with bone culture proven disease. Over a mean of 27.2 months of follow-up 247 patients developed a foot wound and 151 developed 199 foot infections. Osteomyelitis was found in 30 patients: 12% of those with a foot wound and 20% in those with a foot infection. When all wounds were considered, the probe-to-bone test was highly sensitive (0.87) and specific (0.91); the PPV was only 0.57, but the NPV was 0.98. The probe-to-bone test, when used in a population of diabetic patients with a foot wound among whom the prevalence of osteomyelitis was 12%, had a relatively low PPV, but a negative test may exclude the diagnosis. 3
54. Shone A, Burnside J, Chipchase S, Game F, Jeffcoate W. Probing the validity of the probe-to-bone test in the diagnosis of osteomyelitis of the foot in diabetes. Diabetes Care. 2006; 29(4):945. Observational-Dx 81 patients (104 foot ulcers) To determine the validity of the probe-to-bone test in a consecutive series of outpatients. A total of 14 patients had osteomyelitis complicating a single ulcer. A total of 21 ulcers (20.2% of 104) were associated with osteomyelitis. The probe-to-bone test was positive in 8 of these 21 ulcers and in 7 of 83 without associated bone infection (sensitivity 38%, specificity 91%). While the NPV was 85%, the PPV (the probability that a patient with a positive test would have osteomyelitis) was only 53%. The data emphasize that the predictive value of a positive probe-to bone test in the original report was influenced by the high prevalence of osteomyelitis in the population studied. The prevalence of osteomyelitis in the present population was still high at 23.5% patients (20.2% ulcers) but was only approximately one-third of that in the earlier study, and the PPV was correspondingly lower. It is likely that the PPV would be lower still in patients managed in a less-specialized service. 2
55. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://www.acr.org/-/media/ACR/Files/Appropriateness-Criteria/RadiationDoseAssessmentIntro.pdf. Review/Other-Dx N/A To provide evidence-based guidelines on exposure of patients to ionizing radiation. No abstract available. 4
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