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

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ClinicalTrials.gov Identifier: NCT01764984
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : February 4, 2015
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Étienne Belzile, CHU de Quebec-Universite Laval

Study Description
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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.

Condition or disease Intervention/treatment Phase
Unilateral Primary Osteoarthritis of Knee Device: Total knee arthroplasty Phase 4

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls.
Study Start Date : November 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2015

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Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. SF-36 score [ Time Frame: Pre-operative, 12,24,60 months ]
    Standardized General health evaluation and quality of life measuring instrument.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764984


Locations
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Canada, Quebec
Hôpital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hopital du Sacre-Coeur
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Québec
Quebec city, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Zimmer Biomet
Investigators
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Principal Investigator: Etienne L Belzile, MD Centre Hospitalier Universitaire de Quebec - Universite Laval
More Information
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Responsible Party: Étienne Belzile, Principal Investigator; Orthopaedic surgeon, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01764984     History of Changes
Other Study ID Numbers: 5.5.04.12
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Étienne Belzile, CHU de Quebec-Universite Laval:
total knee arthroplasty
trabecular metal
bone mineral density
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases