Clinical trial NCT02931084: Natural Course and Recovery After ACL-injury
Official title: Natural Course and Recovery After ACL-injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2016-10-12
Enrollment: 275
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ACL-injury from 7 different sites in Sweden

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.

Detailed description: Study design: A descriptive and prospective prognostic cohort study, with consecutive recruitment of patients during a 12 month period from seven sites in Sweden Start of recruiting participants is October 2016. Most participants will receive a diagnosis from an orthopedic doctor approximately 2-4 weeks after their knee injury, and undergo rehabilitation for at least the first three months, before a decision regarding ACL reconstruction is taken (in line with current treatment guidelines). The patient cohort will be naturally divided into reconstruction plus rehabilitation, and rehabilitation only. Being included in the study will not affect the choice of treatment.

Patients will be asked to participate at their initial contact with healthcare, after their knee injury. The recruitment process will differ slightly between the different sites, based on the clinical routine.

Patients who accept to participate will complete web-based questionnaires distributed via smart phones or e-mail, once a week the first 6 weeks, every second week up to 3rd month, every month up to 1 year and every second month up to 3 years after initial injury. The length of the questionnaires varies from very short (approximately 10 questions that take 2 minutes to fill in) to longer at specific critical time points. Each time the patient has contact with an orthopedic surgeon, the patient, orthopedic doctor and physiotherapist (if the patient has contact with one) will be asked to answer a questionnaire about choice of treatment (surgery or not). In addition, when the patient reports that they are back to sport activity, the patient and the physiotherapist will be asked to answer a questionnaire about the decision to return to sport. Patients who will have ACL reconstruction will be followed up with new baseline from the time of reconstruction.

Patients recruited from Linköping will have expanded follow-up data collection at baseline and 3, 6, 12 and 24 months after injury. At these follow-ups, a clinical examination will be completed by an orthopedic surgeon or physiotherapist, MRI, and blood and urine samples will be collected. A joint fluid sample will be acquired at baseline, and at the time of ACL reconstruction (if the patient has surgical treatment). Radiographs will be done at baseline and 5 years follow up. Patients who have ACL reconstruction will be followed up with new baseline at the time for reconstruction, but without MRI or blood and urine samples.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Return to physical activity/ sports
timeFrame: 1 year
measure: Knee function, IKDC
timeFrame: 1 year
measure: Osteoarthritis
timeFrame: 5 years
measure: New injuries
timeFrame: 3 years
measure: Factors related to treatment choice
timeFrame: 1 year
Secondary outcomes:
measure: Psychological factors affecting recovery
timeFrame: 2 years
measure: Physical factors affecting recovery, Range of motion
timeFrame: 1 year
measure: IKDC
timeFrame: 2 years
measure: Physical factors affecting recovery, gait
timeFrame: 4 weeks
measure: Physical factors affecting recovery, muscle strength
timeFrame: 6 months
measure: Physical factors affecting recovery, functional performance
timeFrame: 6 months
measure: Physical factors affecting recovery, functional performance
timeFrame: 1 year
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: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.