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

NCT ID: NCT01764984

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2015-01-31

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

Conditions

Unilateral Primary Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trabecular metal

Primary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate.

Group Type: EXPERIMENTAL

Total knee arthroplasty

Intervention Type: DEVICE

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

Titanium

Primary total knee arthroplasty is performed with cemented titanium traditional tibial base plate

Group Type: ACTIVE_COMPARATOR

Total knee arthroplasty

Intervention Type: DEVICE

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

Interventions

Total knee arthroplasty

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

Intervention Type: DEVICE

Other Intervention Names

NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer); NexGen Option Stemmed (Titanium) modular tibia (Zimmer).

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Étienne Belzile

Principal Investigator; Orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Etienne L Belzile, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Quebec - Universite Laval

Locations

Hôpital Maisonneuve Rosemont

Montreal, Quebec, Canada

Hopital du Sacre-Coeur

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Québec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

5.5.04.12

Identifier Type: -

Identifier Source: org_study_id