Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty

Unilateral Primary Osteoarthritis of Knee Clinical Trial

Official title:

Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764984
• Other study ID #: 5.5.04.12
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2012
• Last updated: February 2, 2015
• Start date: November 2005
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

Number of patients: 80 Ages: 55 - 75 years old Sex: male and female Race: all

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2015
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Unilateral Primary Osteoarthritis of Knee

Intervention

Device:
• Total knee arthroplasty
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.

Locations

Country	Name	City	State
Canada	Hopital du Sacre-Coeur	Montreal	Quebec
Canada	Hôpital Maisonneuve Rosemont	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Québec	Quebec city	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Zimmer, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.	Standardized clinical evaluation instrument specific to Total knee arthroplasty population.	Pre-operative, 6,12,24,60 months	No
Secondary	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.	12, 24, 60 months	Yes
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.	Standardized clinical outcome instruments specific to total knee arthroplasty population.	pre-operative, 6,12,24,60 months	No
Secondary	SF-36 score	Standardized General health evaluation and quality of life measuring instrument.	Pre-operative, 12,24,60 months	No