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Clinical Trials/NCT03182647
NCT03182647
Unknown
Not Applicable

Long-term Follow-up of Anterior Cruciate Ligament Injury

Linkoeping University1 site in 1 country300 target enrollmentJune 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Injury
Sponsor
Linkoeping University
Enrollment
300
Locations
1
Primary Endpoint
Self reported knee function
Last Updated
8 years ago

Overview

Brief Summary

Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee injuries. Because it is such a significant injury - requiring a long period of rehabilitation before the injured person is ready to return to physical activity, the burden of injury is high. This can help to explain why so much of orthopaedic research is devoted to evaluating the outcomes of ACL injury. However, while there has been extensive study of short-term (up to 5 years after injury) outcomes, few studies have followed patients beyond 15 years after their ACL injury. This is important because long-term follow-up can provide key insights to guide the information provided to newly injured patients (e.g. to help set realistic expectations of what the injured person can expect of their knee function in the future), and help us evaluate the efficacy of previous treatments.

The primary aim is to assess the influence of an acute ACL injury on knee function and quality of life, 32-37 years after the index injury. Approximately 300 patients injured between 1980 and 1985 will be invited to participate in the study. Patient- and clinician-reported outcomes, and radiographic osteoarthritis will be evaluated.

Detailed Description

Patients injuring their ACL between 1980 and 1985 have periodically been followed since the injury. Now, we plan to contact all patients and invite them to participate. The patients will be asked to 1. complete a questionnaire battery 2. visit the movement laboratory at Linköping University for an objective assessment of knee function and 3. have an x-ray of both knee joints. Baseline information including associated injuries, treatment and activity level exist for all the patients. At that time, rehabilitation was normally completed after 4-6 months for non-operatively treated patients, and nine months after ACL surgery.

Registry
clinicaltrials.gov
Start Date
June 9, 2017
End Date
June 30, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Joanna Kvist

Professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • primary ACL injury between 1980 and 1985, age between 15 and 40 at injury

Exclusion Criteria

  • all patients from the initial cohort will be invited for participation

Outcomes

Primary Outcomes

Self reported knee function

Time Frame: 32-37 years after ACL injury

Knee Injury and Osteoarthritis Outcome Score, KOOS 4 (Pain, Symptoms, Sport/Rec, QOL subscales)

Osteoarthritis

Time Frame: 32-37 years after ACL injury

Development of osteoarthritis examined with tibiofemoral and patellofemoral radiographs

Secondary Outcomes

  • Quality of life(32-37 years after ACL injury)
  • Physical activity(32-37 years after ACL injury)
  • Objective assessment of knee function(32-37 years after ACL injury)
  • Associated injuries and additional surgery(32-37 years after ACL injury)

Study Sites (1)

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