Status:
COMPLETED
Computer Navigation vs Conventional Technique in Knee Arthroplasty
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
The Research Council of Norway
Conditions:
Knee Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
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 ev...
Detailed Description
Protocol 1. Introduction: We will perform a prospective, randomized, clinically controlled RSA trial comparing: 1. Profix cemented bicompartmental knee prosthesis implanted with conventional intr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00782444
Start Date
January 1 2009
End Date
January 1 2023
Last Update
November 21 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Haugesund sanitetsforenings revmatismesykehus
Haugesund, Haugesund, Norway, 5504
2
Lovisenberg diakonale sykehus
Oslo, Oslo County, Norway, 0456
3
Haukeland university hospital
Bergen, Norway, 5021
4
Haugesund hospital
Haugesund, Norway, 5504