NCT06001164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

August 11, 2023

Last Update Submit

August 18, 2023

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Double-bundle

ACTIVE COMPARATOR
Procedure: ACL reconstruction: Double bundle

Single-bundle

ACTIVE COMPARATOR
Procedure: ACL reconstruction: Single bundle

Interventions

ACL reconstruction: Double bundlePROCEDURE

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.

Double-bundle
ACL reconstruction: Single bundlePROCEDURE

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.

Single-bundle

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics, Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 21, 2023

Study Start

April 6, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)