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

April 25, 2019 updated by: Martin Lind, Aarhus University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Division of Sports Trauma, Tage-Hansens Gade 2b

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anterior cruciate ligament rupture

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcome score - IKDC
Time Frame: 12 month
IKDC (international Knee Documentation committee) subjective score (0-100)
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee laxity
Time Frame: 12 month
KT-1000 arthrometer
12 month
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.
12 month
TEGNER
Time Frame: 12 month
Patient reported outcome score (range 0-10)
12 month
Anterior knee pain scale
Time Frame: 12 month
Patient reported outcome score (range 0-100)
12 month
Donor Site morbidity score
Time Frame: 12 month
Patient reported outcome score (range 100-0)
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Danish EC - 110728514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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