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NCT02115451 Clinical Trial

Nonsurgical or Surgical Treatment of ACL Injuries

Anterior Cruciate Ligament Injury Clinical Trial

Official title:
Dynamic Stability of the ACL Deficient Knee

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02115451
Other study ID # 685-06289
Secondary ID
Status Completed
Phase N/A
First received April 14, 2014
Last updated April 24, 2014
Start date January 2007
Est. completion date June 2013

Study information
Verified date April 2014
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: The National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 60 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injury

Locations
Country Name City State
Norway NAR- Department of Orthopaedics, Oslo University Hospital & Nimi Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital University of Delaware

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient-reported knee function (IKDC 2000) 2 years No
Secondary Isokinetic knee extensor and flexor muscle strength 2 years No
Secondary Knee reinjury 2 years No
Secondary Participation in level I, II and III sports 2 years No
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