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

February 2, 2015 updated by: Étienne Belzile, CHU de Quebec-Universite Laval

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve Rosemont
      • Montreal, Quebec, Canada
        • Hopital Du Sacre-Coeur
      • Quebec city, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trabecular metal
Primary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate.
Device: Total knee arthroplasty
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
Other Names:
  • NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer)
  • NexGen Option Stemmed (Titanium) modular tibia (Zimmer).
ACTIVE_COMPARATOR: Titanium
Primary total knee arthroplasty is performed with cemented titanium traditional tibial base plate
Device: Total knee arthroplasty
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
Other Names:
  • NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer)
  • NexGen Option Stemmed (Titanium) modular tibia (Zimmer).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bone Mineral Density (%) from baseline initial value
Time Frame: post-operative 7 to 10 days, 6,12,24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.
Time Frame: Pre-operative, 6,12,24,60 months
Standardized clinical evaluation instrument specific to Total knee arthroplasty population.
Pre-operative, 6,12,24,60 months
number of study subject with implant loosening
Time Frame: 12, 24, 60 months
Radiological evaluation of implant loosening according to Radiographic Knee Society Score at follow-up after total knee arthroplasty.
12, 24, 60 months
Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.
Time Frame: pre-operative, 6,12,24,60 months
Standardized clinical outcome instruments specific to total knee arthroplasty population.
pre-operative, 6,12,24,60 months
SF-36 score
Time Frame: Pre-operative, 12,24,60 months
Standardized General health evaluation and quality of life measuring instrument.
Pre-operative, 12,24,60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Etienne L Belzile, MD, Centre hospitalier universitaire de Québec - Université Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5.5.04.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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