A Prospective Randomized Controlled Trial of a Bioresorbable Calcium Phosphate Paste (α-BSM) in Treatment of Displaced Intra-Articular Calcaneal Fractures
Bibliographic record
Abstract
BACKGROUND: Displaced intra-articular calcaneal fractures are devastating injuries and pose a therapeutic challenge. The purpose of this study was to determine whether open reduction internal fixation (ORIF) plus an injectable bioresorbable calcium phosphate paste (alpha-BSM [bone substitute material]) is superior to ORIF alone in the treatment of calcaneal bone voids encountered after operative treatment of displaced intra-articular calcaneal fractures. METHODS: We prospectively randomized 47 patients with 52 closed displaced intra-articular fractures necessitating operative fixation to receive ORIF alone (n = 28) or ORIF plus alpha-BSM (n = 24). The maintenance of Böhler's angle was evaluated at follow-up visits for more than 1 year. Secondary outcome measures included the SF-36 and lower extremity measure every 6 months, and the Oral Analog Scale (OAS) score at 2 years. RESULTS: There was no difference between the groups in the degree of collapse of Böhler's angle at 6 weeks and 3 months when compared with initial postoperative values. However, at 6 months, the mean collapse of the alpha-BSM and ORIF group was 5.6 degree (SD, 4.5 degree) and ORIF alone was 9.1 degree (SD, 5.8 degree), which was statistically significant (p = 0.03). Final radiographic evaluation after 1 year revealed a Böhler's angle loss of 6.2 degree (SD 5.9 degree) and 10.4 degree (SD 7.1 degree) in alpha-BSM and ORIF and ORIF alone groups, respectively, (p = 0.05). There was no difference between the two groups in regards to secondary outcome measures of general health, limb specific function, and pain past 2 years. CONCLUSION: These results support the use of an injectable, in situ hardening calcium phosphate paste to fill the bone void after a displaced intra-articular calcaneal fracture. There was no impact on general health, limb specific function, and pain past 2 years and no associated complications with alpha-BSM use, supporting it safety as an augment to ORIF.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 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".