NCT00156598

Brief Summary

Other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. We want to learn whether these elevated levels are associated with any adverse effects. We hope this study will help us identify which type of patients have elevated levels of metal in their blood.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Status
terminated

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, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.6 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

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

5.8 years

First QC Date

September 7, 2005

Last Update Submit

June 28, 2012

Conditions

Osteoarthritis

Keywords

metal ion concentration

Eligibility Criteria

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

Local surgeon's patients who have had a hip implant.

You may qualify if:

  • Group 1 - unilateral hip replacement with metal on metal prosthesis, well functioning.
  • Group 2 - loosening of plastic and metal prosthesis Group 3 - osteoarthritis of the hip and awaiting total hip replacement

You may not qualify if:

  • renal dysfunction
  • other types of metal implants or dental prostheses
  • rheumatoid arthritis
  • hip infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lorence Trick, MD

    University of Texas Health Science Center Department of Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 2, 2012

Record last verified: 2012-06