NCT00293774

Brief Summary

A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

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

June 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
10.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

6.6 years

First QC Date

February 16, 2006

Last Update Submit

July 27, 2021

Conditions

Arthroplasty, Replacement, Hip

Keywords

ProspectiveConventional therapyRegistryMetal-on-metalCeramic-on-ceramicHip Arthroplasty

Study Arms (2)

Standard

Standard hip replacement subjects (polyethylene)

Alternative Bearing

Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Males between the ages of 18-65 and females between the ages of 18-55

You may qualify if:

  • documentation of DJD of hip
  • patient at least 18 years
  • patient able to provide written consent
  • Male under 65 years, female under 56 years
  • Orthopedic surgeon has received appropriate training to implant an alternative device

You may not qualify if:

  • renal failure (MOM only)
  • child bearing potential (MOM only)
  • inappropriate femoral anatomy, including evidence of osteoporosis
  • inflammatory arthritis (MOM)
  • Unwilling to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Bone and Joint Health Institute

Calgary, Alberta, T2N 2X6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples retained for cobalt and chromium metal ion level analysis on select cohort.

Study Officials

  • James MacKenzie, M.D.

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Greg O'Connor, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

June 1, 2004

Primary Completion

January 1, 2011

Study Completion

July 16, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

CA(1)