Computer Navigation vs Conventional Technique in Knee Arthroplasty (CAOS)
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Purpose
Project summary:
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 | Intervention |
|---|---|
|
Knee Osteoarthritis Rheumatoid Arthritis |
Procedure: computer navigation |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 200 |
| 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
Show Detailed Description Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- men and women age 50-85 years old
- primary and secondary knee osteoarthritis
- rheumatic arthritis of the knee
- well compensated heart or lung disease(ASA-grad 1-3)
- patients recruited from orthopaedic departments at Haugesund hospital og Haugesund Sanitetsforenings Revmatismesjukehus, Haukeland university hospital, Lovisenberg Diakonale hospital
- informed consent
- MMS-score > 20 elir. , tas MMS også dag 2
- Hb > 11,5 for women and Hb > 13 for men
Exclusion Criteria:
- advanced systemic disease
- general or local infection
- neurological or myogenic disease
- Paget's disease of bone
- bone cysts in the tibia or femur > 2 cm in diameter and within 2 cm from the articular surface
- liver disease
- uncontrolled haematological disease
- B-TRC < 165
- B-Hb < 11,5 for women
- B-Hb < 13 for men
- cancer
- uncontrollable heart or lung disease (ASA-class 4)
- dementia
- immobile hips
- hip replacement in ipsilateral hip
- knee injury < 1år earlier
- metal allergy
- extreme valgus deformity > 15 degrees or curvature of the tibia, necessitating extramedullary device
- earlier fracture of the femur makes it impossible to use intramedullary rod Osteotomy of the proximal tibia og distal femur
- BMI > 35
- Only one knee recruited per patient
Contacts and Locations| Norway | |
| Haukeland university hospital | |
| Bergen, Norway, 5021 | |
| Haugesund hospital | |
| Haugesund, Norway, 5504 | |
| Haugesund sanitetsforenings revmatismesykehus | |
| Haugesund, Norway, 5504 | |
| Lovisenberg diakonale sykehus | |
| Oslo, Norway, 0456 | |
| Study Director: | Ove Furnes, Phd, MD | Haukeland University Hospital |
More Information
Publications:
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT00782444 History of Changes |
| Other Study ID Numbers: | 2007/12587 |
| Study First Received: | October 30, 2008 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Osteoarthritis Osteoarthritis, Knee Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013