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 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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".