A Comparison of Large Diameter Metal Heads vs. Small Diam... | NCT02049892

Studies
A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements

NCT02049892

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Dec 5, 2017Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Total Hip Replacement

Interventions

Metal Ion Levels

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2013

Primary Completion Date

Jan 1, 2016Actual

Completion Date

Feb 1, 2016Actual

First Submitted Date

Jan 22, 2014

First Submission Date that Met QC Criteria

Jan 28, 2014

First Posted Date

Jan 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2017

Last Update Posted Date

Dec 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
Metal Ion			Other: Metal Ion Levels

Name	Type	Description	Arm Group Labels	Other Names
Metal Ion Levels	Other		Metal Ion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metal Ion levels	We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Orthopedic patients with prior hip replacement.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States