Early Outcome Assessment of Revision Total Knee Arthropla... | NCT01156558

Studies
Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

NCT01156558

Sponsor

Rothman Institute Orthopaedics

Status

Completed

Last Update Posted

Mar 31, 2011Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Revision Total Knee Replacement

Interventions

Not provided

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

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

Jun 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jul 1, 2010

First Submission Date that Met QC Criteria

Jul 1, 2010

First Posted Date

Jul 5, 2010Estimated

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

Mar 30, 2011

Last Update Posted Date

Mar 31, 2011Estimated

Name	Class
DePuy Orthopaedics	INDUSTRY

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

Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.

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

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

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant survivorship 2 years following revision TKA

Secondary Outcomes

Measure	Description	Time Frame
Knee Society Score
KOOS score
Radiographic assessment 1 and 2 years following revision surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used
Cases with at least 2 year follow-up
Cases with regular follow-up visits completed

Exclusion Criteria:

Cemented sleeves
Patients with less than two year follow-up completed
Cases lost to follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sequential assessment of 100 patients who have received a revision knee surgery for which metaphyseal sleeve was used in femoral and/or tibial side starting August 2007. Patients must meet inclusion/exclusion criteria for enrollment.

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	Mar 31, 2011
Reset	Apr 28, 2011
Release	Nov 7, 2011
Reset	Dec 7, 2011

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 30, 2011		Yes
Mar 31, 2011