Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

Not Applicable

Completed

• Conditions: ACL Injury

• Registration Number: NCT06001164
• Lead Sponsor: Tampere University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-08
• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-18
• Last Update Submitted: 2023-08-18
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
osteoarthritis (OA)	15 years	which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
Lysholm score	15 years	subjective evaluation form. Scale 0-100 (100=best)
graft failures	15 years	which group has more graft failures? The number of graft failures was assessed by revision surgery.
Range on motion (ROM) of the knee	15 years	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°).
One leg hop test	15 years	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.
Pivot shift	15 years	which group has more positive pivot shift tests? Always compared to a "healthy" knee.
IKDC subjective evaluation. Scale 0-100 (100=best)	15 years	subjective evaluation form
IKDC objective score. Scale 1-4 (1=best)	15 years	Overall evaluation of the knee
KT-1000 arthrometer difference	15 years	Anteroposterior translation. Always compared to a "healthy" knee. mm.

Trial Locations

Locations (1)

Department of Orthopaedics, Tampere University Hospital; 🇫🇮 Tampere, Finland