Nonsurgical or Surgical Treatment of ACL Injuries

April 24, 2014 updated by: Oslo University Hospital

Dynamic Stability of the ACL Deficient Knee

The aim of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury

Study Overview

Status

Completed

Conditions

Detailed Description

This study is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee.

Study Type

Observational

Enrollment (Actual)

143

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

  • Norway
      • Oslo, Norway, 0407
        • NAR- Department of Orthopaedics, Oslo University Hospital & Nimi

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

13 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Athletically active anterior cruciate ligament injured patients

Description

Inclusion Criteria:

  • Anterior cruciate ligament rupture within 3 months of injury
  • Preinjury participation in level I or II sports at least twice a week

Exclusion Criteria:

  • Current or previous injury to the contralateral leg
  • Another grade III ligament injury, fracture, full-thickness articular cartilage damage

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

Cohorts and Interventions

Group / Cohort
Surgical treatment
Patients who undergo rehabilitation and anterior cruciate ligament reconstruction, other surgical interventions may be performed
Nonsurgical treatment
Patients who undergo rehabilitation without anterior cruciate ligament reconstruction, other surgical interventions may be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient-reported knee function (IKDC 2000)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Isokinetic knee extensor and flexor muscle strength
Time Frame: 2 years
2 years
Knee reinjury
Time Frame: 2 years
2 years
Participation in level I, II and III sports
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Collaborators

University of Delaware

Investigators

  • Principal Investigator: May Arna Risberg, PT PhD, Norwegian Research Center for Active Rehabilitation

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

January 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 685-06289

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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