Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty
Primary Purpose
Unilateral Primary Osteoarthritis of Knee
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Total knee arthroplasty
Sponsored by

About this trial
This is an interventional treatment trial for Unilateral Primary Osteoarthritis of Knee focused on measuring total knee arthroplasty, trabecular metal, bone mineral density
Eligibility Criteria
Inclusion Criteria:
- Tri-compartmental knee arthrosis
- 55 to 75 years of age
- Stable health condition
Exclusion Criteria:
- Inflammatory arthritis
- Osteonecrosis
- Infection
- Amputation (AK or BK)
- Biphosphonates
- Metal in the proximal tibia (25cm)
- History of fracture or osteotomy
- Ligament instability
Sites / Locations
- Hôpital Maisonneuve Rosemont
- Hopital du Sacre-Coeur
- Centre Hospitalier Universitaire de Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trabecular metal
Titanium
Arm Description
Primary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate.
Primary total knee arthroplasty is performed with cemented titanium traditional tibial base plate
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.
Standardized clinical evaluation instrument specific to Total knee arthroplasty population.
number of study subject with implant loosening
Radiological evaluation of implant loosening according to Radiographic Knee Society Score at follow-up after total knee arthroplasty.
Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.
Standardized clinical outcome instruments specific to total knee arthroplasty population.
SF-36 score
Standardized General health evaluation and quality of life measuring instrument.
Full Information
NCT ID
NCT01764984
First Posted
February 17, 2012
Last Updated
February 2, 2015
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT01764984
Brief Title
Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty
Official Title
Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Number of patients: 80 Ages: 55 - 75 years old Sex: male and female Race: all
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Primary Osteoarthritis of Knee
Keywords
total knee arthroplasty, trabecular metal, bone mineral density
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trabecular metal
Arm Type
Experimental
Arm Description
Primary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate.
Arm Title
Titanium
Arm Type
Active Comparator
Arm Description
Primary total knee arthroplasty is performed with cemented titanium traditional tibial base plate
Intervention Type
Device
Intervention Name(s)
Total knee arthroplasty
Other Intervention Name(s)
NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer), NexGen Option Stemmed (Titanium) modular tibia (Zimmer).
Intervention Description
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
Primary Outcome Measure Information:
Title
Change in Bone Mineral Density (%) from baseline initial value
Description
Evaluation of Bone Mineral Density using dual energy x-ray absorptiometry (DEXA) scan under tibial base plate implant after Total knee arthroplasty.
Time Frame
post-operative 7 to 10 days, 6,12,24 months
Secondary Outcome Measure Information:
Title
Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.
Description
Standardized clinical evaluation instrument specific to Total knee arthroplasty population.
Time Frame
Pre-operative, 6,12,24,60 months
Title
number of study subject with implant loosening
Description
Radiological evaluation of implant loosening according to Radiographic Knee Society Score at follow-up after total knee arthroplasty.
Time Frame
12, 24, 60 months
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.
Description
Standardized clinical outcome instruments specific to total knee arthroplasty population.
Time Frame
pre-operative, 6,12,24,60 months
Title
SF-36 score
Description
Standardized General health evaluation and quality of life measuring instrument.
Time Frame
Pre-operative, 12,24,60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Tri-compartmental knee arthrosis
55 to 75 years of age
Stable health condition
Exclusion Criteria:
Inflammatory arthritis
Osteonecrosis
Infection
Amputation (AK or BK)
Biphosphonates
Metal in the proximal tibia (25cm)
History of fracture or osteotomy
Ligament instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne L Belzile, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Quebec - Universite Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Maisonneuve Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital du Sacre-Coeur
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Québec
City
Quebec city
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
12. IPD Sharing Statement
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Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty
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