NCT00962351

Brief Summary

This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.

Trial Health

90
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 Oct 2003

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 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

October 1, 2003

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

7 years

First QC Date

August 19, 2009

Last Update Submit

August 14, 2015

Conditions

Non-inflammatory Degenerative Joint Disease

Keywords

total hip replacementprimary cementless total hip arthroplastymetal ionmetal-on-metal

Outcome Measures

Primary Outcomes (1)

  • cobalt, chromium, and titanium ion levels in blood and urine

    Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years

Secondary Outcomes (2)

  • Hip function

    Pre-op, 6 months,1 year, 2 years, 3 years, 5 years

  • Durability

    6 months, 1 year, 2 years, 3 years, 5 years

Study Arms (3)

Metal-on-Polyethylene

OTHER
Procedure: Total Hip Replacement

Metal-on-Metal, 28mm femoral head

OTHER
Procedure: Total Hip Replacement

Metal-on-Metal, 36mm femoral head

OTHER
Procedure: Total Hip Replacement

Interventions

Total Hip ReplacementPROCEDURE
Metal-on-Metal, 28mm femoral headMetal-on-Metal, 36mm femoral headMetal-on-Polyethylene

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing cementless primary total hip replacement
  • Receiving acetabular cup of 52mm or greater
  • Preoperative level of function and pain same as for conventional hip replacement
  • Likelihood of obtaining relief of pain and improved function
  • Full skeletal maturity
  • Ability to follow instructions
  • Good general health
  • Willing to return for follow-up evaluations
  • X-ray evaluation confirming the presence of NIDJD
  • Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants

You may not qualify if:

  • Age less than 40 years or greater than 80 years at time of surgery
  • Patients templated to receive an acetabular component smaller than 52mm in diameter
  • Presence of a previous prosthetic hip replacement device in the hip joint to be operated
  • Previous girdlestone procedure or surgical fusion of the hip to be operated
  • Acute femoral neck fracture
  • Above knee amputation of the contralateral and/or ipsilateral leg
  • Patients with a diagnosis of inflammatory degenerative arthritis
  • Skeletally immature
  • Evidence of active infections that may spread to other areas of the body
  • The presence of a highly communicable disease that may limit follow-up
  • Presence of known active metastatic or neoplastic disease
  • Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
  • Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
  • Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
  • Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306, United States

Location

Department of Orthopaedic Surgery, University of Western Ontario

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

  • Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. doi: 10.1007/s11999-008-0540-9. Epub 2008 Oct 15.

    PMID: 18855089RESULT

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • C. Anderson Engh, Jr., MD

    Anderson Orthopaedic Research Institute

    PRINCIPAL INVESTIGATOR

  • Steven J. MacDonald, MD

    Department of Orthopaedic Surgery, University of Western Ontario

    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
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

October 1, 2003

Primary Completion

October 1, 2010

Study Completion

October 1, 2013

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

CA(1)US(1)