Retrieval and Analysis of Orthopedic Implants at Revision... | NCT01425021

Studies
Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

NCT01425021

Sponsor

University of Utah

Status

Completed

Last Update Posted

Aug 19, 2015Estimated

Enrollment

199Actual

Phase

Not provided

Conditions

Total Joint Revisions

Interventions

Not provided

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

Aug 2015

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

Aug 2010

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Aug 25, 2011

First Submission Date that Met QC Criteria

Aug 26, 2011

First Posted Date

Aug 29, 2011Estimated

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

Aug 17, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The goal of this is to improve durability of total joint replacements in patients, thereby improving clinical outcomes and implant performance. To reach this objective, our research program would like to assess the safety, efficacy, performance, and durability of FDA approved biomaterial and implant designs used in joint replacements.

Detailed Description

The objective of the investigation will be to determine the mechanism of material failure and identify any design features that put the implant at risk for early failure. Normally all implants are discarded. The investigators will collect the implants indicated for removal and if there are impressive findings the investigators will perform research on the implants, otherwise the implants will be discarded. All patients will be followed prospectively after informed consent is signed. The implants that are chosen for research will be assessed for implant wear and failure at a lab appropriate for evaluating the particular concern.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

199Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total hip/knee joint revisions		All University of Utah orthopedic patients who have had total or partial joint arthroplasties at the time of revision surgery.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
determine the mechanism of material failure		10 years

Secondary Outcomes

Measure	Description	Time Frame
identify any design features that put the implant at risk for early failure.		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who will be undergoing revision total joint surgery will be asked to participate in this study.

Exclusion Criteria:

Patients who are not undergoing revision total joint surgery.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing revision total joint surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chris Peters, MD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah Orthopaedic Center		Salt Lake City	Utah	84108	United States