NCT00253877

Brief Summary

This study compares outcomes and metal ion levels between patients who receive the Conserve® Plus Hip System compared to those who have received a standard hip replacement in a recent study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

July 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

6.8 years

First QC Date

November 10, 2005

Last Update Submit

March 6, 2020

Conditions

Osteoarthritis

Keywords

OsteoarthritisHip Resurfacing

Outcome Measures

Primary Outcomes (1)

  • Rate of complications

    Any complications pertaining specifically to the implant

    2 years

Secondary Outcomes (1)

  • Survivorship rate Clinical efficacy (Pain, Function, Radiographic outcome and Patient Satisfaction) Blood and Urine Ion Levels

    2 years

Study Arms (2)

Conserve Plus Hip Resurfacing

ACTIVE COMPARATOR

Conserve Plus Hip Resurfacing group. Complication rate will be compared between groups.

Other: Complication rate

Total Hip Replacement

OTHER

Historical Total Hip Replacement control group of recently published conventional total hip replacement results (Williams, 2002). Complication rate will be compared between groups.

Other: Complication rate

Interventions

Complication rateOTHER

All patients in the active comparator group received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology. The complication rate and clinical efficacy will be recorded and compared to the Total Hip Replacement historical control group.

Conserve Plus Hip ResurfacingTotal Hip Replacement

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (1)

  • Kim PR, Beaule PE, Laflamme GY, Dunbar M. Causes of early failure in a multicenter clinical trial of hip resurfacing. J Arthroplasty. 2008 Sep;23(6 Suppl 1):44-9. doi: 10.1016/j.arth.2008.05.022.

    PMID: 18722302RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Paul Kim, MD, FRCS(C)

    OHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 15, 2005

Study Start

July 1, 2003

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

CA(3)