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Trabecular Metal Mesh Tibial Monoblock RSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00405379
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : April 10, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Osteoarthritis Device: Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Using Roentgen Stereophotogrammetric Analysis of Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty Component "TMM".
Study Start Date : July 2002
Primary Completion Date : August 2006
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. micromotion of tibial component [ Time Frame: 2 years postoperative ]

Secondary Outcome Measures :
  1. subjective outcomes measured with health outcome questionnaires sf36, WOMAC [ Time Frame: 2 years postoperative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008

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

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