Computer Navigation vs Conventional Technique in Knee Arthroplasty

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 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.

Conditions

• Knee Osteoarthritis
• Rheumatoid Arthritis

Interventions

PROCEDURE

Computer navigated knee replacement

Total knee replacement performed with the use of navigation system from Brainlab with the Profix total knee implant.

PROCEDURE

Conventional knee replacement

Conventional total knee replacement performed in a traditional way with the use of intramedullary rods, with the Profix implant.

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Ove Furnes, Phd, MD · Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2023-01-31

Completion

2023-01-31

Countries

• Norway

Study Locations