Clinical trial NCT01353326: Bone Mineral Density (BMD) in Cemented Versus Cementless Hip Resurfacing
Official title: Randomized Clinical Trial of a Cemented Versus Cementless Femoral Component for Metal on Metal Hip Resurfacing Assessing Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: non-inflammatory degenerative joint disease
hip resurfacing
bone mineral density
cemented
cementless
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Corin
First posted: 2011-05-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in BMD (g/cm2)
timeFrame: 12 months
Secondary outcomes:
measure: Implant Migration
timeFrame: 24 months
measure: Harris Hip Score (HHS) Questionnaire
timeFrame: 24 months
measure: WOMAC Questionnaire to assess functionality
timeFrame: 24 months
measure: RAND-36 Item Health Survey
timeFrame: 24 months
measure: UCLA Activity Score
timeFrame: 24 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Dr. Paul Beaule, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tice A, Kim P, Dinh L, Ryu JJ, Beaule PE. A randomised controlled trial of cemented and cementless femoral components for metal-on-metal hip resurfacing: a bone mineral density study. Bone Joint J. 2015 Dec;97-B(12):1608-14. doi: 10.1302/0301-620X.97B12.36110.