Anterior Cruciate Ligament Injury Clinical Trial
— ACLLTFUOfficial title:
Long-term Follow-up of Anterior Cruciate Ligament Injury
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Linkoping University | Linkoping | Ostergotland |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University |
Sweden,
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
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 |
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