A Prospective, Randomized Clinical Trial Comparing an Antibiotic-Impregnated Bioabsorbable Bone Substitute With Standard Antibiotic-Impregnated Cement Beads in the Treatment of Chronic Osteomyelitis and Infected Nonunion
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Bibliographic record
Abstract
OBJECTIVES: We sought to compare the effectiveness of an antibiotic-impregnated bioabsorbable bone substitute (BBS, tobramycin-impregnated medical-grade calcium sulfate) with antibiotic-impregnated polymethylmethacrylate (PMMA) cement beads after surgical débridement in patients with chronic nonhematogenous osteomyelitis and/or infected nonunion. DESIGN: A prospective, randomized clinical trial. SETTING: A university-affiliated teaching hospital. PATIENTS/PARTICIPANTS: Thirty patients requiring surgical treatment for chronic long bone infection or infected nonunion were included: BBS (15 patients, mean age 44.1 years) PMMA (15 patients, mean age 45.6 years). INTERVENTION: Patients were randomized to receive either BBS or PMMA to the bone void created by surgical débridement. MAIN OUTCOME MEASUREMENTS: Eradication of infection, new bone growth, rate of union, repeat operative procedures complications. RESULTS: Patients were followed for a mean 38 months (range, 24-60 months). One patient was lost to follow-up in each group. In the BBS group, infection was eradicated in 86% (12 of 14) of patients. Seven of eight patients achieved union of their nonunion, and five patients underwent seven further surgical procedures. In the PMMA group, infection was eradicated in 86% (12 of 14) of patients. Six of eight patients achieved union of their nonunion, and nine patients required 15 further surgical procedures. There were more reoperations in the PMMA group (15 versus seven, P = 0.04), and these procedures tended to be of greater magnitude. CONCLUSIONS: The results of this preliminary study suggest that, in the treatment of chronic osteomyelitis and infected nonunion, the use of an antibiotic-impregnated BBS is equivalent to standard surgical therapy in eradicating infection and that it may reduce the number of subsequent surgical procedures. A larger, definitive study on this topic is required.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it