Long-term Follow-up of Anterior Cruciate Ligament Injury

Anterior Cruciate Ligament Injury Clinical Trial

— ACLLTFU  

Official title:

Long-term Follow-up of Anterior Cruciate Ligament Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03182647
• Other study ID #: ACL LTFU
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2017
• Last updated: June 30, 2017
• Start date: June 9, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2017
• Source: Linkoeping University
• Contact: Joanna Kvist, Professor
• Phone: +4613284664
• Email: joanna.kvist[@]liu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 47 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injury
• Wounds and Injuries

Intervention

Procedure:
• Surgically treatment of the ACL
Surgical initial ACL treatment

Other:
• Non surgical initial ACL treatment
Non surgical initial ACL treatment

Locations

Country	Name	City	State
Sweden	Linkoping University	Linkoping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Andersson C, Odensten M, Gillquist J. Knee function after surgical or nonsurgical treatment of acute rupture of the anterior cruciate ligament: a randomized study with a long-term follow-up period. Clin Orthop Relat Res. 1991 Mar;(264):255-63. — View Citation

Meunier A, Odensten M, Good L. Long-term results after primary repair or non-surgical treatment of anterior cruciate ligament rupture: a randomized study with a 15-year follow-up. Scand J Med Sci Sports. 2007 Jun;17(3):230-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported knee function	Knee Injury and Osteoarthritis Outcome Score, KOOS 4 (Pain, Symptoms, Sport/Rec, QOL subscales)	32-37 years after ACL injury
Primary	Osteoarthritis	Development of osteoarthritis examined with tibiofemoral and patellofemoral radiographs	32-37 years after ACL injury
Secondary	Quality of life	ACL-Quality of Life scale (ACL-QoL)	32-37 years after ACL injury
Secondary	Physical activity	Total time over the previous week spent doing moderate, and vigorous activity AND accelerometer measures	32-37 years after ACL injury
Secondary	Objective assessment of knee function	Concentric isokinetic muscle strength	32-37 years after ACL injury
Secondary	Objective assessment of knee function	Functional testing; stand-up test	32-37 years after ACL injury
Secondary	Objective assessment of knee function	Functional testing; hopping performance in one leg hop for distance	32-37 years after ACL injury
Secondary	Objective assessment of knee function	Postural control (one leg stand test)	32-37 years after ACL injury
Secondary	Associated injuries and additional surgery	Patient reported	32-37 years after ACL injury