Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
275 participants
OBSERVATIONAL
2016-10-31
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ACL injury
Patients with an acute (not more than 6 weeks old) anterior cruciate ligament (ACL) injury
Rehabilitation
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 reconstruction
Some of the patients with ACL injury will have reconstruction of the ACL. These will be followed as a new group.
Rehabilitation
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 reconstruction
Approximately half of the patients will have ACL-reconstruction after an initial time of rehabilitation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rehabilitation
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 reconstruction
Approximately half of the patients will have ACL-reconstruction after an initial time of rehabilitation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age at time of ACL injury: 15-40 years
Exclusion Criteria
* 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)
15 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Linkoeping University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joanna Kvist
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joanna Kvist, Professor
Role: PRINCIPAL_INVESTIGATOR
IMH Linkoping University, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Linkoping University
Linköping, Östergötland County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NACOX
Identifier Type: -
Identifier Source: org_study_id