Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

ACL Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06001164
• Other study ID #: R20001
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Department of Orthopaedics, Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	osteoarthritis (OA)	which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)	15 years
Primary	Pivot shift	which group has more positive pivot shift tests? Always compared to a "healthy" knee.	15 years
Primary	KT-1000 arthrometer difference	Anteroposterior translation. Always compared to a "healthy" knee. mm.	15 years
Primary	Lysholm score	subjective evaluation form. Scale 0-100 (100=best)	15 years
Primary	IKDC subjective evaluation. Scale 0-100 (100=best)	subjective evaluation form	15 years
Primary	IKDC objective score. Scale 1-4 (1=best)	Overall evaluation of the knee	15 years
Primary	graft failures	which group has more graft failures? The number of graft failures was assessed by revision surgery.	15 years
Primary	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
Primary	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