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

Ottawa Hospital Research Institute

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Conserve; Device: Cormet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01353326

2008058-01H

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Cementless Hip Resurfacing

Active Comparator group

Description:

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

Treatment:

Device: Cormet

Cemented Hip Resurfacing

Active Comparator group

Description:

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

Treatment:

Device: Conserve