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Completed

NCT Number: NCT06001164

Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

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.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics, Tampere University Hospital

Tampere, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

ACL reconstruction: Double bundle

Procedure

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

Procedure

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.

Primary outcomes

  1. osteoarthritis (OA)

    Time frame: 15 years

    which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)

  2. Pivot shift

    Time frame: 15 years

    which group has more positive pivot shift tests? Always compared to a "healthy" knee.

  3. KT-1000 arthrometer difference

    Time frame: 15 years

    Anteroposterior translation. Always compared to a "healthy" knee. mm.

  4. Lysholm score

    Time frame: 15 years

    subjective evaluation form. Scale 0-100 (100=best)

  5. IKDC subjective evaluation. Scale 0-100 (100=best)

    Time frame: 15 years

    subjective evaluation form

  6. IKDC objective score. Scale 1-4 (1=best)

    Time frame: 15 years

    Overall evaluation of the knee

  7. graft failures

    Time frame: 15 years

    which group has more graft failures? The number of graft failures was assessed by revision surgery.

  8. Range on motion (ROM) of the knee

    Time frame: 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°).

  9. One leg hop test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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