Bone Mineral Density (BMD) in Cemented Versus Cementless Hip Resurfacing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-15

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing.

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Detailed Description

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Recent research is inconclusive regarding the degree to which the density or strength of the bone around the hip implant is preserved following a hip resurfacing system. Certainly, there are many factors which contribute to the preservation of bone mineral density - we are studying the role of cement. More specifically, we are trying to compare outcomes between patients who receive the cementless Cormet Hip Resurfacing System to those who receive the cemented CONSERVE® Plus Total Resurfacing Hip System. Therefore, the primary purpose of the current study is to compare the bone mineral density between the cementless and cemented hip resurfacing systems. We are also comparing patients who receive these two different hip systems in terms of their x-rays and how they are managing with their hip.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cementless Hip Resurfacing

Patients randomized into the Cementless Hip Resurfacing Group will have their hip resurfaced with the cementless Cormet / Corin Hip Resurfacing System.

Group Type ACTIVE_COMPARATOR

Cormet

Intervention Type DEVICE

Cementless hip resurfacing system

Cemented Hip Resurfacing

Patients randomized into the Cemented Hip Resurfacing Group will have their hip resurfaced with the cemented Conserve Plus Total Resurfacing Hip System.

Group Type ACTIVE_COMPARATOR

Conserve

Intervention Type DEVICE

Cemented hip resurfacing system

Interventions

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Cormet

Cementless hip resurfacing system

Intervention Type DEVICE

Conserve

Cemented hip resurfacing system

Intervention Type DEVICE

Other Intervention Names

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Cormet Hip Resurfacing System Corin Conserve Plus Total Resurfacing Hip System Wright

Eligibility Criteria

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Inclusion Criteria

* Must be undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease
* must be skeletally mature, as determined by Risser sign or reaching 18 years of age
* Is reasonable expectation that patient will remain available for all FU's scheduled over course of 5 years

Exclusion Criteria

* Previous fusions, acute femoral neck fractures, and above knee amputations
* evidence of active local infection
* neurologic or musculoskeletal disease that may adversely affect gait or weight bearing
* having previously undergone ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device
* BMI \>35
* neuropathic joints
* severe documented psychiatric disease
* patients requiring structural bone grafts
* documented allergy to cobalt chromium molybdenum
* ipsilateral girdlestone
* sickle cell disease
* significant femoral head or neck deformity, or significant acetabular wall deficiency
* patients with renal failure, defined as serum creatinine greater that 180 µmol/L

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No