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The Best Method for ACL Reconstruction.

NCT03192761 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-07-11

No results posted yet for this study

Summary

The investigators wish to compare 3 methods for reconstruction of the anterior cruciate ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract graft, as these methods influence the muscles around the knee differently. Methods using bone-patella tendon-bone and hamstrings are performed as standard operations, and the use of the iliotibial tract graft using a new method of reconstruction.

The purpose is:

1. To assess whether one of three different grafts used for reconstruction of the ACL shows superior results compared to the others in relation to mechanical stability and re-rupture rates.
2. To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others in subjective patient outcome measures.
3. To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering specific symptoms and complications that can be related to donor-site morbidity.
4. To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering muscular power, muscle coordination, and function.

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

PROCEDURE

ACL reconstruction hamstrings

HG reconstruction is performed according to the standard procedure of the department: A double semi-Tendinosus and gracillis graft is used. Placement of the bony tunnels is anatomical, and the femoral tunnel is positioned through the antero-medial portal. Fixation proximally is by CL-endobutton and at the tibia by Intrafix sheet and screw

PROCEDURE

ACL reconstruction patella tendon

PTBG reconstruction is performed according to the standard procedure of the department: A bone patella tendon bone graft of 1 cm width from the midportion of the tendon is used. Placement of the bony tunnels is anatomical, the femoral being positioned through the antero-medial portal. Fixation proximally and distally is by interference screws.

PROCEDURE

ACL reconstruction iliotibial tract

TIFLG reconstruction is performed as follows: The TIFL graft is harvested using two lateral incisions. The graft is left attached to the distal iliotibial tract. Placement of the bony tunnels is anatomical, the femoral being drilled outside-in. The tibial drill tunnel is made by retrograde drilling 20 mm, leaving cortical bone at the distal end of the tunnel. Fixation distally is by CL-endobutton or interference screw and on femur by an interference screw outside-in.

Sponsors & Collaborators

  • Lars Konradsen

    lead OTHER

Principal Investigators

  • Michael Krogsgaard · Head of section

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-12-31
Completion
2021-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192761 on ClinicalTrials.gov