Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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The purpose of this study is to compare double-bundle and single-bundle techniques for ACL reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is better than the SB technique.

Official Title
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Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 15-Year Results

Conditions
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ACL Injury

Intervention / Treatment
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* Procedure: ACL reconstruction: Double bundle
* Procedure: ACL reconstruction: Single bundle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for the study, patients had to meet certain criteria, including primary ACL reconstruction, closed growth plates, and no ligamentous injuries to the contralateral knee. Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double-bundle<br> | Procedure: ACL reconstruction: Double bundle<br>* DB: Two tunnels were created on the femoral side through an anteromedial portal. These tunnels were created manually. On the tibial side, the tunnels were created using a guide to ensure they matched the anatomic insertion site of the ACL at the tibia. The hamstring grafts for the procedure were then harvested from the same leg and doubled. The femoral side was fixed from the inside out, whereas the tibial side was fixed from the outside in. bioresorbable screws were used.<br>|
| Active Comparator: Single-bundle<br> | Procedure: ACL reconstruction: Single bundle<br>* SB: The femoral tunnel was created using an anteromedial portal. A freehand technique was used. For the tibial tunnel, a tibial guide was used to ensure it was positioned at the midpoint of the tibial ACL attachment site. The tendons of the semitendinosus and gracilis muscles were then harvested, doubled over, and inserted through the tibial tunnel, extending into the femur, and fixed with metallic or bioabsorbable interference screws.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| osteoarthritis (OA) | which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA) | 15 years | 
| Pivot shift | which group has more positive pivot shift tests? Always compared to a healthy knee. | 15 years | 
| KT-1000 arthrometer difference | Anteroposterior translation. Always compared to a healthy knee. mm. | 15 years | 
| Lysholm score | subjective evaluation form. Scale 0-100 (100=best) | 15 years | 
| IKDC subjective evaluation. Scale 0-100 (100=best) | subjective evaluation form | 15 years | 
| IKDC objective score. Scale 1-4 (1=best) | Overall evaluation of the knee | 15 years | 
| graft failures | which group has more graft failures? The number of graft failures was assessed by revision surgery. | 15 years | 
| Range on motion (ROM) of the knee | Which group has more lack of knee extension or lack of knee flexion? Injured knee is always compared to a contralateral healthy knee. Measurements were performed with a goniometer. ROM included lack of passive extension (normal < 3°, nearly normal 3-5°, abnormal 6-10°, and severely abnormal > 10°) and lack of passive flexion (normal 0-5°, nearly normal 6-15°, abnormal 16-25°, and severely abnormal > 25°). | 15 years | 
| One leg hop test | One leg hop test was performed to assess the functional capacity of the knee. The patient hopped a maximum length three times on each leg separately and the best result was recorded for both legs. The result of the operated leg was then compared with that of the non-operated leg. | 15 years |