Rehabilitation Treatment of Anterior Cruciate Ligament Rupture

September 30, 2025 updated by: Martin Lind, Aarhus University Hospital

The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury.

The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

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

Study Contact

  • Name: Torsten G Nielsen, PT
  • Phone Number: +4540491184
  • Email: torsne@rm.dk

Study Contact Backup

  • Name: Martin Lind, Professor
  • Phone Number: +4530248244
  • Email: martli@rm.dk

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
        • Contact:
          • Martin Lind, Professor
          • Phone Number: +45 30248244
          • Email: martli@rm.dk
        • Contact:
          • Torsten Nielsen, coordinator
          • Phone Number: +45 40491184
          • Email: torsne@rm.dk

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 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We will include 400 patients with Anterior cruciate ligament injury. Patients will be included at different orthopaedic Clinics at 5 hospitals in Region Midtjylland.

Description

Inclusion Criteria:

  • Anterior cruciate ligament injury where rehabilitation regime is selected as treatment.

Exclusion Criteria:

  • Other knee ligament instability
  • Rheumatoid arthritis
  • Morbus Bechterews Disease

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patient reported outcome score (IKDC)
Time Frame: Baseline - 2 Years
The International Knee Documentation Committee (0-100)
Baseline - 2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patient reported outcome score (KOOS)
Time Frame: Baseline - 2 Years
Knee injury and Osteoarthritis Outcome Score (0-100)
Baseline - 2 Years
Changes in patient reported outcome score (KNEES-ACL)
Time Frame: Baseline - 2 Years
Knee Numeric-Entity Evaluation Score (0-100)
Baseline - 2 Years
Changes in patient reported outcome score (TEGNER)
Time Frame: Baseline - 2 Years
Activity scale (0-10)
Baseline - 2 Years

Collaborators and Investigators

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

Sponsor

Aarhus University Hospital

Collaborators

Herning Hospital
Horsens Hospital
Regionshospitalet Silkeborg
Central Jutland Regional 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)

August 15, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Danish EC: 1-10-72-25-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be available for other researchers

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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