Computer Navigation vs Conventional Technique in Knee Arthroplasty (CAOS)
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|ClinicalTrials.gov Identifier: NCT00782444|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2008
Last Update Posted : March 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Rheumatoid Arthritis||Procedure: Computer navigated knee replacement Procedure: Conventional knee replacement||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Computer Navigation vs Conventional Technique in Knee Arthroplasty. A Prospective, Randomised, Clinical and Radiostereometric Trial|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Computer navigated knee replacement
Computer navigation system from Brainlab, vector vision, kolibri.
Procedure: Computer navigated knee replacement
Total knee replacement performed with the use of navigation system from Brainlab with the Profix total knee implant.
Placebo Comparator: Conventional knee replacement
Conventional total knee replacement is performed with intramedullary guides in the traditional way.
Procedure: Conventional knee replacement
Conventional total knee replacement performed in a traditional way with the use of intramedullary rods, with the Profix implant.
- longevity of the implant [ Time Frame: 2yrs for RSA, 10 yrs in vivo ]
- Function of the knee [ Time Frame: 2 yrs ]
- Bleeding [ Time Frame: 1 week ]
- complications [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782444
|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|