Natural Course and Recovery After ACL-injury

NCT02931084 | Unknown

• 1 other identifier: NACOX
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

The natural course after ACL injury is not well described in the literature. Every year about 7000 people, a majority aged 15-30 years old, injure their anterior cruciate ligament (ACL) in Sweden. About 3500 go through surgical treatment and rehabilitation. Despite the large amount of research on ACL-injuries, there are still many patients who have unsatisfactory outcomes regarding instability, decreased activity level, and quality of life, not being able to return to sport as well as an increased risk for osteoarthritis. The general aim of the study is to evaluate the natural course and recovery after ACL injury. Specific aims:

• To evaluate physical, psychological and contextual factors affecting recovery after anterior cruciate ligament (ACL) injury. Recovery is related both to natural course and to treatment chosen
• To evaluate factors affecting the decision for which treatment to choose (ACL reconstruction and rehabilitation or rehabilitation alone)
• To evaluate factors affecting the decision for return to sports
• To study development of knee osteoarthritis after ACL-injury
• To study epidemiology of acute knee trauma
• To study risk factors for new injuries after ACL-injury These aims will be pursued by consequently and prospectively following patients who sustain a new ACL injury in a multicenter study including approximately 800 patients. Assessment methods will be questionnaires to patients, orthopedic doctors and physical therapists. A sub-cohort of 130 patients will undergo multiple clinical and functional examination as well as MRIs and blood, urine and joint fluid samples.

Conditions

Anterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (5)

• Return to physical activity/ sports

  Patients report when they are back to unrestricted physical activity or sports

  1 year

• Knee function, IKDC

  The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function.

  1 year

• Osteoarthritis

  Development of osteoarthritis examined with x-rays at 5 years

  5 years

• New injuries

  Reported new knee injuries

  3 years

• Factors related to treatment choice

  Questionnaires to patients, orthopedic surgeon and physical therapist about the treatment decision

  1 year

Secondary Outcomes (7)

• Psychological factors affecting recovery

  2 years

• Physical factors affecting recovery, Range of motion

  1 year

• IKDC

  2 years

• Physical factors affecting recovery, gait

  4 weeks

• Physical factors affecting recovery, muscle strength

  6 months

Study Arms (2)

ACL injury

Patients with an acute (not more than 6 weeks old) anterior cruciate ligament (ACL) injury

Other: Rehabilitation

ACL reconstruction

Some of the patients with ACL injury will have reconstruction of the ACL. These will be followed as a new group.

Other: Rehabilitation; Procedure: ACL reconstruction

Interventions

Rehabilitation OTHER

In line with current treatment guidelines, patients will undergo rehabilitation for at least the first three months, before a decision regarding ACL reconstruction is taken

ACL injury; ACL reconstruction

ACL reconstruction PROCEDURE

Approximately half of the patients will have ACL-reconstruction after an initial time of rehabilitation

ACL reconstruction

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with ACL-injury from 7 different sites in Sweden

You may qualify if:

• Patients with a knee injury (ACL injury)
• Age at time of ACL injury: 15-40 years

You may not qualify if:

• ACL injury/ACL reconstruction on the same knee
• Serious knee injuries to the injured knee, ex fracture that require separate treatment
• ACL injury more than 6 weeks ago
• Inability to understand written and spoken Swedish language
• Cognitive impairments
• Other illness/injury that impairs function (e.g. fibromyalgia, rheumatic diseases and other diagnosis that causes chronic pain)

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linkoping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (6)

• Sonesson S, Kuster RP, Kvist J. Accelerometer-assessed physical activity patterns during the first two years after a non-surgically treated ACL injury. Phys Ther Sport. 2023 Nov;64:123-132. doi: 10.1016/j.ptsp.2023.09.011. Epub 2023 Oct 12.

  PMID: 37864852 DERIVED

• Sonesson S, Kvist J. Bilateral changes in knee joint laxity during the first year after non-surgically treated anterior cruciate ligament injury. Phys Ther Sport. 2022 Nov;58:173-181. doi: 10.1016/j.ptsp.2022.10.011. Epub 2022 Oct 26.

  PMID: 36368151 DERIVED

• Casula V, Tajik BE, Kvist J, Frobell R, Haapea M, Nieminen MT, Gauffin H, Englund M. Quantitative evaluation of the tibiofemoral joint cartilage by T2 mapping in patients with acute anterior cruciate ligament injury vs contralateral knees: results from the subacute phase using data from the NACOX study cohort. Osteoarthritis Cartilage. 2022 Jul;30(7):987-997. doi: 10.1016/j.joca.2022.02.623. Epub 2022 Apr 11.

  PMID: 35421548 DERIVED

• Filbay S, Kvist J. Fear of Reinjury Following Surgical and Nonsurgical Management of Anterior Cruciate Ligament Injury: An Exploratory Analysis of the NACOX Multicenter Longitudinal Cohort Study. Phys Ther. 2022 Feb 1;102(2):pzab273. doi: 10.1093/ptj/pzab273.

  PMID: 34939109 DERIVED

• Grevnerts HT, Sonesson S, Gauffin H, Ardern CL, Stalman A, Kvist J. Decision Making for Treatment After ACL Injury From an Orthopaedic Surgeon and Patient Perspective: Results From the NACOX Study. Orthop J Sports Med. 2021 Apr 15;9(4):23259671211005090. doi: 10.1177/23259671211005090. eCollection 2021 Apr.

  PMID: 33948447 DERIVED

• Kvist J, Gauffin H, Tigerstrand Grevnerts H, Ardern C, Hagglund M, Stalman A, Frobell R. Natural corollaries and recovery after acute ACL injury: the NACOX cohort study protocol. BMJ Open. 2018 Jun 27;8(6):e020543. doi: 10.1136/bmjopen-2017-020543.

  PMID: 29950463 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine and joint fluid will be collected from approximately 120 patientes rom one site of the study

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joanna Kvist, Professor

  IMH Linkoping University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)