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Trabecular Metal Mesh Tibial Monoblock RSA

This study has been completed.
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by:
Dalhousie University
ClinicalTrials.gov Identifier:
NCT00405379
First received: November 28, 2006
Last updated: April 8, 2008
Last verified: April 2008
History of Changes
  Purpose

Trabecular Metal(TM) is a relatively new technology and its use in knee replacement is quite different from the more conventional total knee replacement (arthroplastie). The aim of incorporating TMM into the material used for the knee replacement (tibial prostheses) is to improve initial fixation of the prosthesis at the time of implantation (surgery) and to improve long term prosthesis survival by encouraging and improving bone ingrowth.


Condition Intervention
Osteoarthritis
 Device: Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Using Roentgen Stereophotogrammetric Analysis of Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty Component "TMM".

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dalhousie University:

Primary Outcome Measures:
  • micromotion of tibial component [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective outcomes measured with health outcome questionnaires sf36, WOMAC [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: July 2002
Study Completion Date: February 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty
    new porous metal tibial component with potential to result in improved bone in-growth and implant integration with proximal tibia
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 55 and 80
  • Primary osteoarthritis of the knee
  • Mono-articular disease (Charnley Modified Type A)

Exclusion Criteria:

  • Significant co-morbidity affecting ability to ambulate
  • Flexion contracture greater than 15°
  • Tibial subluxation greater than 10 mm on standing AP radiograph
  • Greater than 10° of varus or 15° of valgus
  • Extension lag greater than 10°
  • Lateral or medial collateral ligament instability (> 10° varus/valgus)
  • Previous osteotomy about the knee
  • Previous arthroplasty of the knee
  • Previous patellectomy
  • Posterior cruciate ligament deficiency
  • Leg length discrepancy greater than 10 mm
  • Morbid obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405379

Sponsors and Collaborators
Dalhousie University
Wright Medical Technology
Investigators
Principal Investigator: Michael J Dunbar, MD FRCSC PhD Dalhousie University & Capital Districk Health Authority
  More Information

No publications provided by Dalhousie University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Michael Dunbar MD, FRCSC, PhD, Dalhousie University
ClinicalTrials.gov Identifier: NCT00405379     History of Changes
Other Study ID Numbers: DAL06-02, CDHA-RS/2002-096
Study First Received: November 28, 2006
Last Updated: April 8, 2008
Health Authority: Canada: Health Canada

Keywords provided by Dalhousie University:
arthroplasty
RSA
Osteoarthritis
trabecular metal mesh

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013