Informasjon om prosjekttittel 'Improving the Treatment of Anterior Cruciate Ligament Tears in Norway – who should have surgery?'
Improving the Treatment of Anterior Cruciate Ligament Tears in Norway – who should have surgery?
|Detaljer om prosjektet - kategori||Detaljer om prosjektet - verdi|
|Prosjektleder:||Caroline Kooy Tveiten|
|Veileder(e):||Rune B. Jakobsen, Lars Engebretsen|
|Medarbeider(e):||Andreas Persson, Guri Ranum Ekås, Håvard Visnes|
Background: ACL injuries affect more than 4,000 patients in Norway each year. It is a life-changing event, which often leaves the patient with an unsatisfactory knee-function and predisposing osteoarthritis. The general consensus in Scandinavia is that patients who manage to regain acceptable knee function after rehabilitation alone, should not have surgery - a consensus mainly based on a single RCT. Further, only low-quality evidence supports «no difference» between the two treatment options of surgical and non-surgical treatment. Studies with high external validity are lacking, and they are difficult and expensive to perform. Yet, physicians need to be able to offer precise information on treatment and prognosis, and to give personalized advice to their patients. Despite years of research on treatment of ACL injuries to answer this important clinical question, it remains uncertain who should be recommended reconstructive surgery, and who should not.
Purpose: To improve the treatment of Anterior Cruciate Ligament (ACL) tears by investigating the outcome of early reconstruction vs. primarily non-surgical treatment. This will be achieved through the implemention of a fairly new and innovative study design.
Methods: This study will be conducted through a register-based, multi-center RCT, by implementation of a randomization module in the already well-established Norwegian Knee Ligament Register (NKLR). Included patients are those between 16 – 50 years old, with a total ACL-rupture and without additional injuries that needs surgical repair. Patients will mainly be followed by registration of Patient Reported Outcome Measures (PROMS) at 2, 5 and 10 years.
Implications: The results from the trial will significantly improve our knowledge of the subjective and objective outcome for the different treatment options for ACL-injuries. It will provide information that will enhance the shared-decision making of clinicians and patients both nationally and internationally, and contribute to revised evidence-based guidelines. The establishment of the R-RCT infrastructure is very likely to impact how studies in the Norwegian Knee Ligament Registry (NKLR) will be performed in the future, and the dissemination of the knowledge of register-based RCTs in the orthopedic community will hopefully encourage implementation in other orthopedic registries.