Trabecular Metal Mesh Tibial Monoblock RSA
A Prospective Randomized Controlled Trial Using Roentgen Stereophotogrammetric Analysis of Trabecular Metal Mesh Tibial Monoblock Knee Arthroplasty Component "TMM".
2 other identifiers
interventional
67
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2002
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 28, 2006
CompletedFirst Posted
Study publicly available on registry
November 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedApril 10, 2008
April 1, 2008
4.1 years
November 28, 2006
April 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
micromotion of tibial component
2 years postoperative
Secondary Outcomes (1)
subjective outcomes measured with health outcome questionnaires sf36, WOMAC
2 years postoperative
Interventions
new porous metal tibial component with potential to result in improved bone in-growth and implant integration with proximal tibia
Eligibility Criteria
You may qualify if:
- Age between 55 and 80
- Primary osteoarthritis of the knee
- Mono-articular disease (Charnley Modified Type A)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dalhousie Universitylead
- Stryker Trauma and Extremitiescollaborator
Related Publications (1)
Astephen Wilson JL, Wilson DA, Dunbar MJ, Deluzio KJ. Preoperative gait patterns and BMI are associated with tibial component migration. Acta Orthop. 2010 Aug;81(4):478-86. doi: 10.3109/17453674.2010.501741.
PMID: 20809746DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Dunbar, MD FRCSC PhD
Dalhousie University & Capital Districk Health Authority
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2006
First Posted
November 30, 2006
Study Start
July 1, 2002
Primary Completion
August 1, 2006
Study Completion
February 1, 2007
Last Updated
April 10, 2008
Record last verified: 2008-04