Clinical trial NCT03182647: Long-term Follow-up of Anterior Cruciate Ligament Injury
Official title: Long-term Follow-up of Anterior Cruciate Ligament Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2017-06-09
Enrollment: 300
Sex: ALL
Minimum age (years): 47
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Baseline data from the time for injury were collected consequently. The initial 167 patients were included in a randomised clinical trial of surgical vs. non-surgical treatment and the following patients were treated according to common practise at that time.

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.

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

Primary outcomes:
measure: Self reported knee function
timeFrame: 32-37 years after ACL injury
measure: Osteoarthritis
timeFrame: 32-37 years after ACL injury
Secondary outcomes:
measure: Quality of life
timeFrame: 32-37 years after ACL injury
measure: Physical activity
timeFrame: 32-37 years after ACL injury
measure: Objective assessment of knee function
timeFrame: 32-37 years after ACL injury
measure: Objective assessment of knee function
timeFrame: 32-37 years after ACL injury
measure: Objective assessment of knee function
timeFrame: 32-37 years after ACL injury
measure: Objective assessment of knee function
timeFrame: 32-37 years after ACL injury
measure: Associated injuries and additional surgery
timeFrame: 32-37 years after ACL injury
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Linkoping University
state: Ostergotland
Study officials:
affiliation: IMH Linkoping University, Sweden
name: Joanna Kvist, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1600-0838.2006.00547.x.
citation: 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.
citation: Filbay S, Andersson C, Gauffin H, Kvist J. Prognostic Factors for Patient-Reported Outcomes at 32 to 37 Years After Surgical or Nonsurgical Management of Anterior Cruciate Ligament Injury. Orthop J Sports Med. 2021 Aug 11;9(8):23259671211021592. doi: 10.1177/23259671211021592. eCollection 2021 Aug.
citation: Kvist J, Filbay S, Andersson C, Ardern CL, Gauffin H. Radiographic and Symptomatic Knee Osteoarthritis 32 to 37 Years After Acute Anterior Cruciate Ligament Rupture. Am J Sports Med. 2020 Aug;48(10):2387-2394. doi: 10.1177/0363546520939897.