NCT06001164

Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• ACL Injury

Interventions

Type	Name	Description
PROCEDURE	ACL reconstruction: Double bundle	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.
PROCEDURE	ACL reconstruction: Single bundle	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.

Timeline

• Start date: 2021-04-06
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

1 site across 1 country: Finland