Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02173483
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Lind, Aarhus University Hospital

Brief Summary:
The purpose of this study is to determine whether there is a difference in muscle strength after anterior cruciate ligament comparing 2 surgery technics. Using either autograft hamstrings tendon or a autograft quadriceps tendon.

Condition or disease Intervention/treatment Phase
Ligament; Laxity, Knee Rupture of Anterior Cruciate Ligament Procedure: Quadriceps graft Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Randomised Controlled Trial
Study Start Date : May 2014
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Quadriceps graft
Proximally from patella the Quadriceps graft is harvested and used as a knew anterior cruciate ligament after rupture.
Procedure: Quadriceps graft
Hamstrings Graft
The Hamstrings graft is harvested and used as a knew anterior cruciate ligament after rupture.
Procedure: Quadriceps graft



Primary Outcome Measures :
  1. Patient reported outcome score - IKDC [ Time Frame: 12 month ]
    IKDC (international Knee Documentation committee) subjective score (0-100)


Secondary Outcome Measures :
  1. Knee laxity [ Time Frame: 12 month ]
    KT-1000 arthrometer

  2. Patient reported outcome score - KOOS [ Time Frame: 12 month ]
    Koos (Knee injury and Osteoarthritis Outcome Score) contains 5 subscores (Pain, ADL, QOL, Symptoms, Sport & recreation). Each subscore ranges from 0-100 where higher values represent a better score.

  3. TEGNER [ Time Frame: 12 month ]
    Patient reported outcome score (range 0-10)

  4. Anterior knee pain scale [ Time Frame: 12 month ]
    Patient reported outcome score (range 0-100)

  5. Donor Site morbidity score [ Time Frame: 12 month ]
    Patient reported outcome score (range 100-0)



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.


Layout table for eligibility information
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): NCT02173483


Locations
Layout table for location information
Denmark
Division of Sports Trauma, Tage-Hansens Gade 2b
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Martin Lind, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02173483     History of Changes
Other Study ID Numbers: Danish EC - 110728514
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Rupture
Wounds and Injuries