Computer Navigation vs Conventional Technique in Knee Arthroplasty (CAOS)
Background: Computer navigation in knee replacement surgery is increasingly being used around the world, but the documentation of its usefulness is lacking. In order to critically evaluate this new surgical method, we want to perform a prospective, randomised clinical trial.
Goal: We evaluate the need for these highly advanced techniques in knee replacement surgery, and the cost-effectiveness. Long term outcome for the patients will be predicted by using the radiostereometric analysis (RSA). Also, data from the Norwegian arthroplasty register will indicate any difference in long term survival of the implant. If there are any differences in the functional outcome or complication rate, between the two groups, this will be detected in this trial.
Method: Patients age 50 through 85 years old, with gonarthritis, in need of knee replacement, are included in the trial. Radiostereometric analysis (RSA), CT-scans, X-rays, clinical evaluation score systems and laboratory measures are used in the evaluation process. A cost-effective analysis is performed based on data from Norwegian life tables, data from SINTEF and from the Norwegian arthroplasty register. Data from the Norwegian arthroplasty register will be statistically analysed separately for all knee replacements done with computer navigation in Norway in the last 5 years. Four Norwegian hospitals will collaborate in this trial (Haukeland university hospital, Haugesund hospital, Haugesund sanitetsforenings hospital for rheumatic diseases and Lovisenberg diakonale hospital) and patients are recruited from all four hospitals.
Scientific impact/challenges: This trial will probably have great impact since good evidence supporting the use of computer navigation in knee surgery is lacking. It is important for the patient to be confident that he/she receives the best treatment, and it is important for the health care providers and funding authorities to have clear evidence when choosing between two different treatment techniques, in order for the patient to benefit.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Computer Navigation vs Conventional Technique in Knee Arthroplasty. A Prospective, Randomised, Clinical and Radiostereometric Trial|
- longevity of the implant [ Time Frame: 2yrs for RSA, 10 yrs in vivo ] [ Designated as safety issue: Yes ]
- Function of the knee [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
- Bleeding [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
- complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Procedure: computer navigation
|Haukeland university hospital|
|Bergen, Norway, 5021|
|Haugesund, Norway, 5504|
|Haugesund sanitetsforenings revmatismesykehus|
|Haugesund, Norway, 5504|
|Lovisenberg diakonale sykehus|
|Oslo, Norway, 0456|
|Study Director:||Ove Furnes, Phd, MD||Haukeland University Hospital|