NCT02049892

Brief Summary

Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

2.1 years

First QC Date

January 22, 2014

Last Update Submit

December 1, 2017

Conditions

Total Hip Replacement

Keywords

Total Hip ReplacementMetal Ion2-5 years after surgeryAsymptomatic

Outcome Measures

Primary Outcomes (1)

  • Metal Ion levels

    We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement

    2 years

Study Arms (1)

Metal Ion

Other: Metal Ion Levels

Interventions

Metal Ion LevelsOTHER
Metal Ion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Orthopedic patients with prior hip replacement.

You may qualify if:

  • One total hip replacement, either a large metal head (\>40) or a small metal head (\<30) on a polyethylene bearing surface.
  • to 5 years s/p surgery minimum. No symptoms

You may not qualify if:

  • Any other bearing surface besides metal on poly, no other joint replacements, symptomatic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 30, 2014

Study Start

December 1, 2013

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

US(1)