Back to resultsDouble-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction
Primary Purpose
ACL Injury
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
ACL reconstruction: Double bundle
ACL reconstruction: Single bundle
Sponsored by
About this trial
This is an interventional treatment trial for ACL Injury
Eligibility Criteria
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: -
Sites / Locations
- Department of Orthopaedics, Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Double-bundle
Single-bundle
Arm Description
Outcomes
Primary Outcome Measures
osteoarthritis (OA)
which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
Pivot shift
which group has more positive pivot shift tests? Always compared to a "healthy" knee.
KT-1000 arthrometer difference
Anteroposterior translation. Always compared to a "healthy" knee. mm.
Lysholm score
subjective evaluation form. Scale 0-100 (100=best)
IKDC subjective evaluation. Scale 0-100 (100=best)
subjective evaluation form
IKDC objective score. Scale 1-4 (1=best)
Overall evaluation of the knee
graft failures
which group has more graft failures? The number of graft failures was assessed by revision surgery.
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°).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06001164
First Posted
August 11, 2023
Last Updated
August 18, 2023
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06001164
Brief Title
Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction
Official Title
Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 15-Year Results
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double-bundle
Arm Type
Active Comparator
Arm Title
Single-bundle
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction: Double bundle
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction: Single bundle
Intervention Description
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 Outcome Measure Information:
Title
osteoarthritis (OA)
Description
which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
Time Frame
15 years
Title
Pivot shift
Description
which group has more positive pivot shift tests? Always compared to a "healthy" knee.
Time Frame
15 years
Title
KT-1000 arthrometer difference
Description
Anteroposterior translation. Always compared to a "healthy" knee. mm.
Time Frame
15 years
Title
Lysholm score
Description
subjective evaluation form. Scale 0-100 (100=best)
Time Frame
15 years
Title
IKDC subjective evaluation. Scale 0-100 (100=best)
Description
subjective evaluation form
Time Frame
15 years
Title
IKDC objective score. Scale 1-4 (1=best)
Description
Overall evaluation of the knee
Time Frame
15 years
Title
graft failures
Description
which group has more graft failures? The number of graft failures was assessed by revision surgery.
Time Frame
15 years
Title
Range on motion (ROM) of the knee
Description
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°).
Time Frame
15 years
Title
One leg hop test
Description
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.
Time Frame
15 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Department of Orthopaedics, Tampere University Hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction
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