Long-term Follow-up of Anterior Cruciate Ligament Injury

NCT ID: NCT03182647

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-09

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non surgery

Patients were not treated with surgery initially

Non surgical initial ACL treatment

Intervention Type OTHER

Non surgical initial ACL treatment

Surgery

Patients had an initial surgical treatment

Surgically treatment of the ACL

Intervention Type PROCEDURE

Surgical initial ACL treatment

Interventions

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Surgically treatment of the ACL

Surgical initial ACL treatment

Intervention Type PROCEDURE

Non surgical initial ACL treatment

Non surgical initial ACL treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

47 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Joanna Kvist

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanna Kvist, Professor

Role: PRINCIPAL_INVESTIGATOR

IMH Linkoping University, Sweden

Locations

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Linkoping University

Linköping, Östergötland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Joanna Kvist, Professor

Role: CONTACT

+4613284664

Facility Contacts

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Joanna Kvist, Professor

Role: primary

+46 (0) 13 284664

References

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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.

Reference Type RESULT
PMID: 17501866 (View on PubMed)

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.

Reference Type RESULT
PMID: 1997243 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34395684 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32736511 (View on PubMed)

Other Identifiers

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ACL LTFU

Identifier Type: -

Identifier Source: org_study_id

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