Long-term Follow-up of Anterior Cruciate Ligament Injury (ACLLTFU)

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Injury
• Intervention / Treatment: Other: Non surgical initial ACL treatment; Procedure: Surgically treatment of the ACL

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Joanna Kvist, Professor; Phone Number: +4613284664; Email: joanna.kvist@liu.se

Study Locations

• Sweden
  • Ostergotland
    • Linkoping, Ostergotland, Sweden, 58183
      • Recruiting
      • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 47 years to 77 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non surgery; Patients were not treated with surgery initially	Other: Non surgical initial ACL treatment; Non surgical initial ACL treatment
Surgery; Patients had an initial surgical treatment	Procedure: Surgically treatment of the ACL; Surgical initial ACL treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	ACL-Quality of Life scale (ACL-QoL)	32-37 years after ACL injury
Physical activity	Total time over the previous week spent doing moderate, and vigorous activity AND accelerometer measures	32-37 years after ACL injury
Objective assessment of knee function	Concentric isokinetic muscle strength	32-37 years after ACL injury
Objective assessment of knee function	Functional testing; stand-up test	32-37 years after ACL injury
Objective assessment of knee function	Functional testing; hopping performance in one leg hop for distance	32-37 years after ACL injury
Objective assessment of knee function	Postural control (one leg stand test)	32-37 years after ACL injury
Associated injuries and additional surgery	Patient reported	32-37 years after ACL injury

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Joanna Kvist, Professor, IMH Linkoping University, Sweden

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 9, 2017
• Primary Completion (ANTICIPATED): December 31, 2017
• Study Completion (ANTICIPATED): June 30, 2018

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (ACTUAL): June 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ACL LTFU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No