Long-term Follow-up of Anterior Cruciate Ligament Injury

• Conditions: Anterior Cruciate Ligament Injury
• Interventions: Procedure: Surgically treatment of the ACL; Other: Non surgical initial ACL treatment

• Registration Number: NCT03182647
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-07
• Study Start: 2017-06-09
• Study First Posted: 2017-06-09
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02
• Primary Completion: 2017-12-31
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery	Surgically treatment of the ACL	Patients had an initial surgical treatment
Non surgery	Non surgical initial ACL treatment	Patients were not treated with surgery initially

Primary Outcome Measures

Name	Time	Method
Self reported knee function	32-37 years after ACL injury	Knee Injury and Osteoarthritis Outcome Score, KOOS 4 (Pain, Symptoms, Sport/Rec, QOL subscales)
Osteoarthritis	32-37 years after ACL injury	Development of osteoarthritis examined with tibiofemoral and patellofemoral radiographs

Secondary Outcome Measures

Name	Time	Method
Quality of life	32-37 years after ACL injury	ACL-Quality of Life scale (ACL-QoL)
Physical activity	32-37 years after ACL injury	Total time over the previous week spent doing moderate, and vigorous activity AND accelerometer measures
Objective assessment of knee function	32-37 years after ACL injury	Postural control (one leg stand test)
Associated injuries and additional surgery	32-37 years after ACL injury	Patient reported

Trial Locations

Locations (1)

Linkoping University; 🇸🇪 Linkoping, Ostergotland, Sweden