Clinical trial NCT01764984: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unilateral Primary Osteoarthritis of Knee
Keywords: total knee arthroplasty
trabecular metal
bone mineral density
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2013-01-10
Enrollment: 65
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in Bone Mineral Density (%) from baseline initial value
timeFrame: post-operative 7 to 10 days, 6,12,24 months
Secondary outcomes:
measure: Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.
timeFrame: Pre-operative, 6,12,24,60 months
measure: number of study subject with implant loosening
timeFrame: 12, 24, 60 months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.
timeFrame: pre-operative, 6,12,24,60 months
measure: SF-36 score
timeFrame: Pre-operative, 12,24,60 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Maisonneuve Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur
state: Quebec
city: Quebec city
country: Canada
facility: Centre Hospitalier Universitaire de Québec
state: Quebec
Study officials:
affiliation: Centre Hospitalier Universitaire de Quebec - Universite Laval
name: Etienne L Belzile, MD
role: PRINCIPAL_INVESTIGATOR
References: