Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06001164
Enrollment
153
Registered
2023-08-21
Start date
2021-04-06
Completion date
2022-09-30
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Injury

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.

Interventions

PROCEDUREACL 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.

PROCEDUREACL 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.

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
osteoarthritis (OA)15 yearswhich group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
Pivot shift15 yearswhich group has more positive pivot shift tests? Always compared to a healthy knee.
KT-1000 arthrometer difference15 yearsAnteroposterior translation. Always compared to a healthy knee. mm.
Lysholm score15 yearssubjective evaluation form. Scale 0-100 (100=best)
IKDC subjective evaluation. Scale 0-100 (100=best)15 yearssubjective evaluation form
IKDC objective score. Scale 1-4 (1=best)15 yearsOverall evaluation of the knee
graft failures15 yearswhich group has more graft failures? The number of graft failures was assessed by revision surgery.
Range on motion (ROM) of the knee15 yearsWhich 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 test15 yearsOne 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026