A Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning Device in Hamstring Anterior Cruciate Ligament Reconstruction
Bibliographic record
Abstract
BACKGROUND: Soft tissue grafts are commonly used in surgical reconstruction of the anterior cruciate ligament (ACL). Applying the appropriate tension to the final graft reconstruction has traditionally been performed by the surgeon and is based on the surgeon's experience and perception of applied tension. Problems with manual application of tension to the ACL reconstruction include under- or overtightening the reconstruction, inconsistent tension application among subjects, and variable load application to each strand. PURPOSE: To assess whether measured tensioning of hamstring ACL grafts during fixation improves clinical outcome or knee laxity postoperatively when compared with conventional tensioning maneuvers. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This was a prospective randomized controlled trial of consecutive primary ACL patients. The device group included patients in whom a measured tensioning device was used for graft tensioning (80 N), and the physician group did not use a tensioning device. The primary outcome was KT-1000 arthrometer side-to-side laxity differences between knees at 6, 12, and 18 months postoperatively. Secondary outcomes included the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form and Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QoL) at those intervals. Chi-square and t tests were used for analysis. The study had 90% power to detect a difference of 2 mm between groups. RESULTS: A sample of 127 patients was randomized. Of those, 14 did not have follow-up data and were excluded from this analysis, resulting in a final sample of 113 (55 patients in the device group and 58 in the physician group). No significant differences were found in baseline demographics or comorbidities. There were no significant differences between the groups (physician vs device) at baseline and at 6, 12, and 18 months in side-to-side laxity (4.6 vs 4.7 mm, 1.6 vs 1.3 mm, 1.5 vs 1.3 mm, and 1.1 vs 1.0 mm, respectively), IKDC score (58.2 vs 56.4, 72.0 vs 67.9, 79.9 vs 76.0, and 81.3 vs 78.5, respectively), or ACL-QoL score (998.2 vs 901.2, 1846.4 vs 1647.5, 2150.4 vs 2268.3, and 2436.9 vs 2231.8, respectively). CONCLUSION: Measured tensioning of hamstring ACL grafts during fixation does not improve clinical outcome or knee laxity postoperatively when compared with conventional tensioning maneuvers.
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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 | 0.006 | 0.011 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.012 | 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".