A Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning Device in Hamstring Anterior Cruciate Ligament Reconstruction

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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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