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Evaluation of Bone Mineral Density Changes Using Two Tibial Base Plate Designs in Primary Total Knee Arthroplasty in Young Patient

NCT03970460 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-02-18

No results posted yet for this study

Summary

Arthritic disease in people less than 60 years old is increasingly common. Younger, active individuals often present now to orthopaedic surgeons requiring treatment of knee osteoarthritis. Knee arthroplasty has been offered as a viable option to provide pain relief and improve function in the middle-aged patient.

In a previous study submitted for publication, the investigators have looked at BMD in vivo after total knee replacement comparing two different tibial base plate designs in cemented and uncemented implants in terms of stiffness and modularity, and its effect on bone density changes, synovitis, osteolysis or survivorship. The investigators found a difference of 18% in bone mineral density favoring trabecular metal implant over cemented modular metal-back implant in patient between 55 and 75 years of age. The trabecular metal implant thus behaved as it was expected and preserved bone density in an elderly population.

No randomized clinical trial has looked at cemented titanium tibial insert to uncemented trabecular metal tibia insert in young population. In order to isolate stiffness as study variable, one would aim at randomizing a homogeneous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial baseplate, titanium versus trabecular metal. The trabecular metal implant is closer to human bone modulus of elasticity.

Conditions

Interventions

DEVICE

Primary TKA with cemented modular metal-backed tibial implant

Tibial implant will be done with a cemented implant

DEVICE

Primary TKA with uncemented trabecular metal

Tibial implant will be done with a uncemented implant

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • CHU de Québec

    collaborator UNKNOWN

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    lead OTHER

Principal Investigators

  • Michel Malo, ND · Hôpital Sacré-Coeur de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-05
Primary Completion
2019-12-30
Completion
2020-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03970460 on ClinicalTrials.gov