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

September 30, 2019 updated by: Martin Lind, Aarhus University Hospital

Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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 N, Denmark, 8200
        • Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Laxity
Time Frame: 12 Months
KT-1000 arthrometer
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcome scores
Time Frame: 12 Months
Koos (Knee injury and Osteoarthritis Outcome Score)
12 Months
Patient reported outcome scores
Time Frame: 12 Months
IKDC (International Knee Documentation Committee)
12 Months
Pain measurement
Time Frame: 12 Months
NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)
12 Months

Collaborators and Investigators

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

Sponsor

Aarhus University Hospital

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 (Actual)

January 3, 2019

Primary Completion (Actual)

September 4, 2019

Study Completion (Actual)

September 4, 2019

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Danish EC - 1-10-72-223-18.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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