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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 : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Lars Konradsen, Bispebjerg Hospital

Brief 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.

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

Detailed Description:

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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Change in KNEES-ACL score [ Time Frame: pre-op, 1 year, 2 years ]
    patient-reported outcome measure


Secondary Outcome Measures :
  1. Change in anterior-posterior stability (quantified by Rolimeter) [ Time Frame: pre-op, 1 year, 2 years ]
    Measure of anterio-posterior laxity

  2. Change in graded pivot shift [ Time Frame: pre-op, 1 year, 2 years ]
    Subluxation of the tibia relative to the femur

  3. Change in muscle strength and forward lunge ability [ Time Frame: pre-op, 1 year, 2 years ]
    Result of muscle power and muscle coordination tests



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with an ACL rupture scheduled for ACL reconstruction after clinical investigation by an orthopedic specialist at the Section of Sports Traumatology M51.
  • Age 18-40 years.
  • Patients able to understand given information in relation to the study and to complete out-come questionnaires.

Exclusion Criteria:

  • Patient activity (sports or work) that excludes one or more of the three methods of surgery, e.g. work predominantly performed kneeling would exclude the use of the BPTBG.
  • Other ligament injuries (except non-surgically treated lesion of MCL - medial collateral ligament) to the same knee or ligament injury (except non-surgically treated lesion of MCL - medial collateral ligament) to the contralateral knee
  • Conditions in either knee with pain of such intensity, that participation in the functional tests of this study are impossible.
  • Auto-immune disease that involves lower limb joints or muscles.
  • Local or systemic infection.
  • Actual or previous systemic corticosteroid, chemotherapeutic, or immunosuppressive treatment.
  • BMI>30.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192761


Contacts
Contact: Lars Konradsen +4540284517 Lars.Konradsen@Regionh.dk
Contact: Michael Krogsgaard +4520512714 Michael.Krogsgaard@regionh.dk

Locations
Denmark
Bisppebjerg Hospital Recruiting
Copenhagen, Denmark, 3400
Contact: Michael Krogsgaard    +4520512714    Michael.Krogsgaard@regionh.dk   
Sponsors and Collaborators
Lars Konradsen
Investigators
Study Director: Michael Krogsgaard Head of section

Responsible Party: Lars Konradsen, Senior consultant, clinical professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03192761     History of Changes
Other Study ID Numbers: BBH-ACL-1
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No