Short Term Outcome After Meniscectomy | NCT01158677

Studies
Short Term Outcome After Meniscectomy

NCT01158677

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 14, 2022Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Meniscectomy

Interventions

Meniscectomy

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

Dec 2022

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

Jul 2010Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jul 7, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 8, 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

Dec 13, 2022

Last Update Posted Date

Dec 14, 2022Actual

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

Short term outcome after meniscectomy: a meniscectomy is a very frequent performed orthopedically procedure. The short term outcome is favourable, but some patients keep having residual lesions after surgery.

This prospective study examens the clinical outcome after meniscectomy using questionnaires (KOOS, VAS, SF-36, Tegner) (before the surgery, 3, 6 & 12 months postoperative.) The investigators will also record the further treatment options for the people at risk.

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

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meniscectomy	Procedure	patients undergoing meniscectomy will be asked to complete the KOOS-scale,Vas-scale, Tegner questionnaire, SF-36 questionnaire pre-operatively and at 3, 6 and 12 months post-operatively

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The clinical outcome (residual lesions) after a meniscectomy	KOOS-scale, Vas-scale, Tegner questionnaire, SF-36 questionnaire	12 months post-operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

all the meniscectomy patients (male & female, all ages)

Exclusion Criteria:None

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

all the meniscectomy patients (male & female, all ages)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Verdonk, MD	University Hospital Ghent, Belgium	Principal Investigator

Locations

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

Label	URL
website of University Hospital Ghent, Belgium	View source

Intervention Browse Module

MeSH Terms

ID	Term
D000074403	Meniscectomy

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided