Computer Navigation vs Conventional Technique in Knee Arthroplasty

NCT00782444 | Completed DMC

• 1 other identifier: 2007/12587
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

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 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

Outcome Measures

Primary Outcomes (1)

• longevity of the implant

  2yrs for RSA, 10 yrs in vivo

Secondary Outcomes (3)

• Function of the knee

  2 yrs

• Bleeding

  1 week

• complications

  1 year

Study Arms (2)

Computer navigated knee replacement

ACTIVE COMPARATOR

Computer navigation system from Brainlab, vector vision, kolibri.

Procedure: Computer navigated knee replacement

Conventional knee replacement

PLACEBO COMPARATOR

Conventional total knee replacement is performed with intramedullary guides in the traditional way.

Procedure: Conventional knee replacement

Interventions

Computer navigated knee replacement PROCEDURE

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

Computer navigated knee replacement

Conventional knee replacement PROCEDURE

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

Conventional knee replacement

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• The Research Council of Norway: collaborator

Study Sites (4)

Haugesund sanitetsforenings revmatismesykehus

Haugesund, Haugesund, 5504, Norway

Location

Lovisenberg diakonale sykehus

Oslo, Oslo County, 0456, Norway

Location

Haukeland university hospital

Bergen, 5021, Norway

Location

Haugesund hospital

Haugesund, 5504, Norway

Location

Related Publications (12)

• Chauhan SK, Scott RG, Breidahl W, Beaver RJ. Computer-assisted knee arthroplasty versus a conventional jig-based technique. A randomised, prospective trial. J Bone Joint Surg Br. 2004 Apr;86(3):372-7. doi: 10.1302/0301-620x.86b3.14643.

  PMID: 15125124 BACKGROUND

• Luring C, Bathis H, Tingart M, Perlick L, Grifka J. Computer assistance in total knee replacement - a critical assessment of current health care technology. Comput Aided Surg. 2006 Mar;11(2):77-80. doi: 10.3109/10929080600578925.

  PMID: 16782642 BACKGROUND

• Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. doi: 10.1302/0301-620x.86b6.15456.

  PMID: 15330021 BACKGROUND

• Furnes O, Espehaug B, Lie SA, Vollset SE, Engesaeter LB, Havelin LI. Failure mechanisms after unicompartmental and tricompartmental primary knee replacement with cement. J Bone Joint Surg Am. 2007 Mar;89(3):519-25. doi: 10.2106/JBJS.F.00210.

  PMID: 17332100 BACKGROUND

• Rand JA, Coventry MB. Ten-year evaluation of geometric total knee arthroplasty. Clin Orthop Relat Res. 1988 Jul;(232):168-73.

  PMID: 3383484 BACKGROUND

• Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement. Its effect on survival. Clin Orthop Relat Res. 1994 Feb;(299):153-6.

  PMID: 8119010 BACKGROUND

• Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. doi: 10.1097/00003086-200111000-00041.

  PMID: 11716402 BACKGROUND

• Bathis H, Shafizadeh S, Paffrath T, Simanski C, Grifka J, Luring C. [Are computer assisted total knee replacements more accurately placed? A meta-analysis of comparative studies]. Orthopade. 2006 Oct;35(10):1056-65. doi: 10.1007/s00132-006-1001-3. German.

  PMID: 16953328 BACKGROUND

• Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.

  PMID: 12801417 BACKGROUND

• Hallan G, Aamodt A, Furnes O, Skredderstuen A, Haugan K, Havelin LI. Palamed G compared with Palacos R with gentamicin in Charnley total hip replacement. A randomised, radiostereometric study of 60 HIPS. J Bone Joint Surg Br. 2006 Sep;88(9):1143-8. doi: 10.1302/0301-620X.88B9.18008.

  PMID: 16943462 BACKGROUND

• Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.

  PMID: 7744919 BACKGROUND

• Gothesen O, Espehaug B, Havelin LI, Petursson G, Hallan G, Strom E, Dyrhovden G, Furnes O. Functional outcome and alignment in computer-assisted and conventionally operated total knee replacements: a multicentre parallel-group randomised controlled trial. Bone Joint J. 2014 May;96-B(5):609-18. doi: 10.1302/0301-620X.96B5.32516.

  PMID: 24788494 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ove Furnes, Phd, MD

  Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: November 21, 2025

Record last verified: 2023-01

Locations

NO (4)