ClinicalTrials.gov
ClinicalTrials.gov Menu

Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02918734
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Rosenborgklinikken
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.

The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.


Condition or disease Intervention/treatment Phase
Knee Injuries Device: Endobutton CL BTB Device: Metal interference screw Not Applicable

Detailed Description:

Primary anterior cruciate ligament (ACL) reconstructions with bone-patellar tendon-bone (BPTB) autografts have recently been found to have a lower risk of revision compared with hamstring tendon autografts, and BPTB has again become our graft of choice. Interference screws have been the standard method for fixing the femoral side of a BPTB graft; however problems such as damage of the graft and failure due to nonparallel screw placement have been reported. Cortical fixation using a suspensory system has been used for soft-tissue graft fixation for several years, and a corresponding device, the Endobutton CL BTB Fixation System (Smith & Nephew, Inc., Andover, MA, USA), has become available for fixation of bone-tendon-bone grafts. The clinical results after fixation with the Endobutton CL BTB have been described as promising; however, no randomized controlled trials comparing these two fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.

In this randomized controlled trial, patients undergoing primary ACL reconstruction will be randomized into either an Endobutton group or an interference screw group. The primary aim of the study is to compare these two fixation methods, assessed by patient reported outcomes, laxity, range of motion and muscle strength. Knee related quality of life 2 years after surgery is the primary outcome, measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) subscale "knee related Quality of life (QOL)". Other aims are to see if there is any difference in the integration of the bone block in the femoral tunnel assessed by CT scan, in the risk of developing osteoarthritis assessed by radiographs, or in the risk of a postoperative complication or revision. The patients will be followed up 6 weeks, 6 months, 2 years and 10 years after surgery. CT scan will be performed after 6 months, and radiographs after 2 years and 10 years. In addition details of the rehabilitation will be recorded. Patients undergoing a revision will be followed up but excluded from further comparisons in the study.

Our hypothesis is that there is no difference in the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation, both with a metal interference screw for the tibial fixation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing the Endobutton CL BTB Fixation System With Metal Interference Screws in the Femoral Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction.
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2027
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: Endobutton CL BTB
Femoral fixation of the BPTB autograft with the Endobutton CL BTB Fixation System.
Device: Endobutton CL BTB
ACL reconstruction with Endobutton CL BTB

Active Comparator: Metal interference screw
Femoral fixation of the BPTB autograft with a metal interference screw.
Device: Metal interference screw
ACL reconstruction with metal interference screw




Primary Outcome Measures :
  1. Knee related quality of life [ Time Frame: 2 years ]
    KOOS subscale "knee related Quality of life (QOL)"


Secondary Outcome Measures :
  1. Tegner activity scale [ Time Frame: 6 months, 2 years, 10 years ]
  2. Lachman test [ Time Frame: 6 weeks, 6 months, 2 years, 10 years ]
    Anterior translation of the tibia

  3. Muscular strength [ Time Frame: 6 months, 2 years, 10 years ]
    Biodex dynamometer

  4. Bone block integration [ Time Frame: 6 months ]
    CT scan

  5. Osteoarthritis [ Time Frame: 2 years, 10 years ]
    X-ray radiographs

  6. Range of motion [ Time Frame: 6 weeks, 6 months, 2 years, 10 years ]
  7. Knee related quality of life [ Time Frame: 6 weeks ]
    KOOS subscale "knee related Quality of life (QOL)"

  8. Knee related quality of life [ Time Frame: 6 months ]
    KOOS subscale "knee related Quality of life (QOL)"

  9. Knee related quality of life [ Time Frame: 10 years ]
    KOOS subscale "knee related Quality of life (QOL)"

  10. Lysholm functional knee score [ Time Frame: 6 weeks, 6 months, 2 years, 10 years ]
  11. KOOS [ Time Frame: 6 weeks, 6 months, 2 years, 10 years ]
    Knee injury and Osteoarthritis Outcome Score

  12. Pivot shift test [ Time Frame: 6 weeks, 6 months, 2 years, 10 years ]
    Anteroposterior and rotational stability

  13. KT-1000 arthrometer [ Time Frame: 6 weeks, 6 months, 2 years, 10 years ]
    Anterior translation of the tibia


Other Outcome Measures:
  1. Complications [ Time Frame: Up to 10 years ]
    Registration

  2. Reoperations [ Time Frame: Up to 10 years ]
    Registration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary reconstruction of ACL ruptures
  • Surgery at least 6 weeks after injury
  • The patient must accept and sign the informed consent form before surgery

Exclusion Criteria:

  • Medical indication for using another graft than BPTB autograft (such as history of anterior knee pain or occupations etc. requiring frequent kneeling)
  • Previous major surgical procedures in the same knee
  • Major additional injuries in the knee (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions and major cartilage lesions undergoing cartilage repair)
  • Contralateral ACL injury (treated or untreated)
  • Present or former serious illness that makes follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease)

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): NCT02918734


Contacts
Contact: Trond Olav Lundemo, md trond.olav.lundemo@stolav.no
Contact: Tone Gifstad, md phd tone.gifstad@stolav.no

Locations
Norway
Department of Orthopedic Surgery, St Olavs Hospital Recruiting
Trondheim, Norway
Rosenborgklinikken Recruiting
Trondheim, Norway
Contact: Agnar Tegnander, md phd         
Sponsors and Collaborators
St. Olavs Hospital
Rosenborgklinikken
Investigators
Principal Investigator: Jon Olav Drogset, md phd St. Olavs Hospital

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02918734     History of Changes
Other Study ID Numbers: 2015/993
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Olavs Hospital:
Anterior Cruciate Ligament
Bone-Patellar Tendon-Bone Grafting

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries