Long-term Follow-up of Anterior Cruciate Ligament Injury

NCT03182647 | Unknown

• 1 other identifier: ACL LTFU
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (2)

• Self reported knee function

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

  32-37 years after ACL injury

• Osteoarthritis

  Development of osteoarthritis examined with tibiofemoral and patellofemoral radiographs

  32-37 years after ACL injury

Secondary Outcomes (7)

• 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

• Objective assessment of knee function

  32-37 years after ACL injury

• Objective assessment of knee function

  32-37 years after ACL injury

Study Arms (2)

Non surgery

Patients were not treated with surgery initially

Other: Non surgical initial ACL treatment

Surgery

Patients had an initial surgical treatment

Procedure: Surgically treatment of the ACL

Interventions

Surgically treatment of the ACL PROCEDURE

Surgical initial ACL treatment

Surgery

Non surgical initial ACL treatment OTHER

Non surgical initial ACL treatment

Non surgery

Eligibility Criteria

• Age: 47 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linkoping University

Linköping, Östergötland County, 58183, Sweden

RECRUITING

Related Publications (4)

• 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.

  PMID: 17501866 RESULT

• 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.

  PMID: 1997243 RESULT

• 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.

  PMID: 34395684 DERIVED

• 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.

  PMID: 32736511 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Joanna Kvist, Professor

  IMH Linkoping University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna Kvist, Professor

CONTACT

+4613284664; joanna.kvist@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: June 9, 2017
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)