NCT00911599

Brief Summary

The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

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

August 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

5.8 years

First QC Date

May 29, 2009

Last Update Submit

March 2, 2020

Conditions

Hip JointOsteoarthritisArthroplasty

Keywords

Individuals undergoing unilateral total hip replacement.

Outcome Measures

Primary Outcomes (1)

  • Metal ion levels

    To compare the metal ion levels between the advanced metal system and the traditional metal on polyethylene total hip replacement system.

    24 months

Secondary Outcomes (6)

  • Dislocation Rate

    24 months

  • Complications

    24 months

  • Change in Harris Hip Score

    24 months

  • Change in RAND-36 Health Survey

    24 months

  • Change in UCLA Questionnaire

    24 months

  • +1 more secondary outcomes

Study Arms (2)

Conserve Total Hip with BFH

ACTIVE COMPARATOR

CONSERVE® A-Class Total Hip with BFH technology. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.

Diagnostic Test: Blood metal ion levels

Metal with Polyethylene Liner

ACTIVE COMPARATOR

Metal on polyethylene total hip replacement. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.

Diagnostic Test: Blood metal ion levels

Interventions

Blood metal ion levelsDIAGNOSTIC_TEST

Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Conserve Total Hip with BFHMetal with Polyethylene Liner

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals undergoing unilateral total hip replacement.
  • Patients 50 to 70 years of age.

You may not qualify if:

  • Patients who have previously undergone any type of joint replacement.
  • Patients with evidence of active infection.
  • Patients with a documented allergy to cobalt chromium molybdenum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (2)

  • Gofton W, Beaule PE. Serum Metal Ions with a Titanium Modular Neck Total Hip Replacement System. J Arthroplasty. 2015 Oct;30(10):1781-6. doi: 10.1016/j.arth.2015.04.040. Epub 2015 May 9.

    PMID: 26027522RESULT

  • Beaule PE, Kim PR, Hamdi A, Fazekas A. A prospective metal ion study of large-head metal-on-metal bearing: a matched-pair analysis of hip resurfacing versus total hip replacement. Orthop Clin North Am. 2011 Apr;42(2):251-7, ix. doi: 10.1016/j.ocl.2011.01.005.

    PMID: 21435499RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Paul E Beaule, MD, FRCSC

    University of Ottawa / The Ottawa Hospital

    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

May 29, 2009

First Posted

June 2, 2009

Study Start

August 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2013

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)