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

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.

Study Overview

• Status: Completed
• Conditions: ACL Injury
• Intervention / Treatment: Procedure: ACL reconstruction: Double bundle; Procedure: ACL reconstruction: Single bundle

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Department of Orthopaedics, Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Double-bundle	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.
Active Comparator: Single-bundle	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: R20001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No