Short Term Outcome After Meniscectomy

This study is currently recruiting participants.

Verified February 2013 by University Hospital, Ghent

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01158677

First received: July 7, 2010

Last updated: February 1, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2010

Last Updated Date

February 1, 2013

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The clinical outcome (residual lesions) after a meniscectomy [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]

KOOS-scale, Vas-scale, Tegner questionnaire, SF-36 questionnaire

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01158677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Short Term Outcome After Meniscectomy

Official Title ^ICMJE

Short Term Outcome After Meniscectomy

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Meniscectomy

Intervention ^ICMJE

Procedure: Meniscectomy

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

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

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

Exclusion Criteria:None

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Peter Verdonk, MD

peter.verdonk@uzgent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01158677

Other Study ID Numbers ^ICMJE

2010/117

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter Verdonk, MD

University Hospital Ghent, Belgium

Information Provided By

University Hospital, Ghent

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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