Revision Meniscal Transplants; Lateral and Medial | NCT01189357

Studies
Revision Meniscal Transplants; Lateral and Medial

NCT01189357

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jul 14, 2011Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Revision of Meniscal Transplant

Interventions

Not provided

Countries

Belgium

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

Jul 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

Oct 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Aug 25, 2010

First Submission Date that Met QC Criteria

Aug 25, 2010

First Posted Date

Aug 26, 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

Jul 13, 2011

Last Update Posted Date

Jul 14, 2011Estimated

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

During the period 1989-1999, a number of patients underwent a meniscal transplantation. A few transplants were not successful. These patients form the population of this study. They all underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after the failure of the transplants The goal of this study is to evaluate their current medical condition, to perform a survival analysis, and to determine the clinical outcome.

The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36)and clinical examination.

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

19Actual

Label	Type	Description	Intervention Names
failed meniscal transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perform a survival analysis of meniscal transplants. Failure of transplant was defined as replacement of the allograft by a knee prothesis.	The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36) and clinical examination.	20 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Clinical evaluation of the knee after TKP/UKP following a failed meniscal transplant.		20 years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

failed Meniscal transplantation between 1989 and 1999

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

failed meniscal transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
René Verdonk, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent			Belgium