Computer Navigation vs Conventional Technique in Knee Arthroplasty (CAOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00782444
First received: October 30, 2008
Last updated: March 4, 2014
Last verified: March 2014
  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 navigated knee replacement
Procedure: Conventional knee replacement

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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • longevity of the implant [ Time Frame: 2yrs for RSA, 10 yrs in vivo ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782444

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
Sponsors and Collaborators
Haukeland University Hospital
The Research Council of Norway
Investigators
Study Director: Ove Furnes, Phd, MD Haukeland University Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 4, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014