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Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.

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ClinicalTrials.gov Identifier: NCT03800225
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Lind, Aarhus University Hospital

Brief Summary:
The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.

Condition or disease Intervention/treatment Phase
Ligament; Laxity, Knee Anterior Cruciate Ligament Injury Procedure: Repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Repair
Anterior cruciate ligament repair with internal brace after anterior ligament rupture.
Procedure: Repair
Anterior ligament repair with internal brace.

Active Comparator: Patella tendon graft
The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.
Procedure: Repair
Anterior ligament repair with internal brace.




Primary Outcome Measures :
  1. Knee Laxity [ Time Frame: 12 Months ]
    KT-1000 arthrometer


Secondary Outcome Measures :
  1. Patient reported outcome scores [ Time Frame: 12 Months ]
    Koos (Knee injury and Osteoarthritis Outcome Score)

  2. Patient reported outcome scores [ Time Frame: 12 Months ]
    IKDC (International Knee Documentation Committee)

  3. Pain measurement [ Time Frame: 12 Months ]
    NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anterior cruciate ligament rupture

Exclusion Criteria:

  • Current malignant disease
  • Rheumatoid arthritis
  • Other knee ligament instability
  • Obesity BMI >30
  • Morbus Bechterew

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): NCT03800225


Locations
Denmark
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99 Recruiting
Aarhus N, Denmark, 8200
Contact: Martin Lind, Professor    +45 30248244    martli@rm.dk   
Contact: Torsten Nielsen, coordinator    +45 40491184    torsne@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital

Responsible Party: Martin Lind, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03800225     History of Changes
Other Study ID Numbers: Danish EC - 1-10-72-223-18.
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries