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
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".