NCT01353326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 13, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

4.6 years

First QC Date

September 30, 2009

Last Update Submit

March 29, 2018

Conditions

Osteoarthritis

Keywords

non-inflammatory degenerative joint diseasehip resurfacingbone mineral densitycementedcementless

Outcome Measures

Primary Outcomes (1)

  • Percent change in BMD (g/cm2)

    The primary outcome is percent change in BMD (g/cm2) from baseline to the 1-year post-operative interval, as measured radiographically in zone L1. Analysis of periprosthetic BMD will be achieved using 6 zones of the femoral neck, which have been used in previous studies

    12 months

Secondary Outcomes (5)

  • Implant Migration

    24 months

  • Harris Hip Score (HHS) Questionnaire

    24 months

  • WOMAC Questionnaire to assess functionality

    24 months

  • RAND-36 Item Health Survey

    24 months

  • UCLA Activity Score

    24 months

Study Arms (2)

Cementless Hip Resurfacing

ACTIVE COMPARATOR

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

Device: Cormet

Cemented Hip Resurfacing

ACTIVE COMPARATOR

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

Device: Conserve

Interventions

CormetDEVICE

Cementless hip resurfacing system

Also known as: Cormet Hip Resurfacing System, Corin
Cementless Hip Resurfacing
ConserveDEVICE

Cemented hip resurfacing system

Also known as: Conserve Plus Total Resurfacing Hip System, Wright
Cemented Hip Resurfacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa General Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26637673RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Dr. Paul Beaule, MD, FRCSC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

May 13, 2011

Study Start

May 15, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 2, 2018

Record last verified: 2018-03

Locations

CA(1)