Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty
Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls.
1 other identifier
interventional
65
1 country
3
Brief Summary
Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans will be affected by the disease. Despite the relative good track record of total knee replacement, it remains a biomedical device that can fail over time. A recent study looking at the current mechanisms of total knee replacement failures, listed polyethylene wear and osteolysis around implants. The material used for polyethylene insert as well as the conformity of articular surface of implants has been modified to decrease wear. While introducing modularity, the usage of metal backing in tibial base plates became obvious as it offered better stress distribution to the proximal tibial bone. However, it introduced other modes of failures. Micromotion has been demonstrated between the metal backing and the tibial liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision. Factor influencing the surgeon's choice of implant include: reproductibility and longevity of results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of elasticity of the tibial base plate has a direct effect on periprosthetic bone biology. Studies have described a significant decrease in postoperative Bone mineral density (BMD), adjacent to the implants, after total knee replacement. No study, to our knowledge, has looked at BMD in vivo after total knee replacement comparing different tibial base plate designs. Direct effect of changes in design on overall implant survival can be studied with randomized clinical trials isolating specific variables. No randomized clinical trial has looked at tibial insert stiffness and modularity, and it effect on bone density changes, synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study variables, one would aim at randomizing an homogenous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial insert modularity and stiffness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2005
Longer than P75 for phase_4
3 active sites
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
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 4, 2015
February 1, 2015
3.8 years
February 17, 2012
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Bone Mineral Density (%) from baseline initial value
Evaluation of Bone Mineral Density using dual energy x-ray absorptiometry (DEXA) scan under tibial base plate implant after Total knee arthroplasty.
post-operative 7 to 10 days, 6,12,24 months
Secondary Outcomes (4)
Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.
Pre-operative, 6,12,24,60 months
number of study subject with implant loosening
12, 24, 60 months
Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.
pre-operative, 6,12,24,60 months
SF-36 score
Pre-operative, 12,24,60 months
Study Arms (2)
Trabecular metal
EXPERIMENTALPrimary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate.
Titanium
ACTIVE COMPARATORPrimary total knee arthroplasty is performed with cemented titanium traditional tibial base plate
Interventions
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
Eligibility Criteria
You may qualify if:
- Tri-compartmental knee arthrosis
- to 75 years of age
- Stable health condition
You may not qualify if:
- Inflammatory arthritis
- Osteonecrosis
- Infection
- Amputation (AK or BK)
- Biphosphonates
- Metal in the proximal tibia (25cm)
- History of fracture or osteotomy
- Ligament instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Quebec-Universite Lavallead
- Zimmer Biometcollaborator
Study Sites (3)
Hôpital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Hopital du Sacre-Coeur
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1R 2J6, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Etienne L Belzile, MD
Centre Hospitalier Universitaire de Quebec - Universite Laval
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator; Orthopaedic surgeon
Study Record Dates
First Submitted
February 17, 2012
First Posted
January 10, 2013
Study Start
November 1, 2005
Primary Completion
September 1, 2009
Study Completion
January 1, 2015
Last Updated
February 4, 2015
Record last verified: 2015-02