The Best Method for ACL Reconstruction.
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|ClinicalTrials.gov Identifier: NCT03192761|
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
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:
- 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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Reconstruction||Procedure: ACL reconstruction hamstrings Procedure: ACL reconstruction patella tendon Procedure: ACL reconstruction iliotibial tract||Not Applicable|
The purpose of the study is described in the "Brief Summary" section.
Patients scheduled for ACL reconstruction at the Section of Arthroscopic Surgery and Sports Traumatology M51, Department of Orthopedics, Bispebjerg-Frederiksberg Hospital are eligible for this study Eligibility criteria are described in the "Eligibility" section.
The patients are scheduled for ACL surgery at consultation with a doctor from the Section of Arthroscopic Surgery and Sports Traumatology after usual, clinical criteria. The doctor informs the patient about the project, gives the patient the written patient information, and if the patient shows interest in the study, an appointment is scheduled with one of the surgeons involved in the project.
At this appointment the patient is informed about the project by the surgeon. The patients will be granted the reflection time they need before consenting or rejecting.
Before the day of surgery muscle power, muscle coordination and functional tests are performed, and objective tests and PROMs are completed.
Surgery is performed by one of two surgeons experienced in all three methods of surgery as described in the "Arms and Interventions" section.
After the patient is put under general anaesthesia the method of ACL reconstruction is chosen by opening a sealed envelope.
Outcome measures are recorded at 1-year and 2-year follow-up.
All three methods of reconstruction are believed to have the same risk for basic complications: infection (approx. 1%), stiffening of the knee (approx. 2%) and deep venous thrombosis (approx. 1 %)
It is assumed that a 20% difference in a patient reported outcome score (KNEES-ACL) represents a clinically relevant difference. Based on standard deviations for the outcome score, and with a 90% power, significant differences of 20 % can be shown in a sample of 20 patients. Significance level is set at 5%. The investigators aim for 30 patients in each group, considering potential drop-outs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||When the patient has been anaesthetized for surgery, the method of reconstruction is defined by opening a sealed envelope in the operating theatre.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Outcome assessor is not involved in the surgical procedures. Participants wear long trousers at follow-up procedures to mask surgical incisions.|
|Official Title:||The Best Method for ACL Reconstruction. A Study Comparing Reconstructions of Anterior Cruciate Ligament Using Grafts Taken From Three Different Anatomical Locations at the Knee and Thigh. A Randomized Clinical Trial|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
Active Comparator: ACL-reconstruction hamstrings
ACL reconstruction hamstrings
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
Active Comparator: ACL-reconstruction patella tendon
ACL reconstruction patella tendon
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.
Active Comparator: ACL-reconstruction iliotibial tract
ACL reconstruction iliotibial tract
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.
- Change in KNEES-ACL score [ Time Frame: pre-op, 1 year, 2 years ]patient-reported outcome measure
- Change in anterior-posterior stability (quantified by Rolimeter) [ Time Frame: pre-op, 1 year, 2 years ]Measure of anterio-posterior laxity
- Change in graded pivot shift [ Time Frame: pre-op, 1 year, 2 years ]Subluxation of the tibia relative to the femur
- Change in muscle strength and forward lunge ability [ Time Frame: pre-op, 1 year, 2 years ]Result of muscle power and muscle coordination tests
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192761
|Contact: Lars Konradsen||+4540284517||Lars.Konradsen@Regionh.dk|
|Contact: Michael Krogsgaard||+4520512714||Michael.Krogsgaard@regionh.dk|
|Copenhagen, Denmark, 3400|
|Contact: Michael Krogsgaard +4520512714 Michael.Krogsgaard@regionh.dk|
|Study Director:||Michael Krogsgaard||Head of section|