Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?

January 14, 2015 updated by: Mikkel Lindegaard Attrup

A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone

Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2300
        • Not yet recruiting
        • Artroskopisk Center Amager
        • Principal Investigator:
          • Mikkel Attrup
        • Contact:
    • Copenhagen
      • Copenhagen S, Copenhagen, Denmark, 2300
        • Recruiting
        • Artroskopisk Center Amager
        • Contact:
        • Principal Investigator:
          • Mikkel Attrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults who have a meniscus repaired.

Exclusion Criteria:

  • Meniscus not fit for repair.
  • Patients not fit for the repair regime.
  • Arthrosis > stadie 2 (ICRS).
  • Prior attempt of repair of the meniscus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Trephination
A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair.
Procedure: trephination
Artroscopic meniskal repair with trephination.
PLACEBO_COMPARATOR: Normal meniscal repair
standard operation. Normal meniscalrepair.
Procedure: Normal meniscal repair
Artroscopic meniskal repair without trephination.
Other Names:
  • Normal meniscal suture with FastFix device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS Questionnaire
Time Frame: 4 month
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
4 month
KOOS Questionnaire
Time Frame: 12 month
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical meniscus healing
Time Frame: 4 month
4 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm
Time Frame: 4 month
Lysholm questionnaire
4 month
rearthroscopy
Time Frame: 6 month
6 month
KOOS
Time Frame: 12 month
Differences between the to arms in the complete KOOS questionnaire.
12 month
Lysholm
Time Frame: 12 month
Lysholm questionnaire
12 month
IKDC
Time Frame: 12 month
IKDC questionnaire
12 month
IKDC
Time Frame: 4 month
IKDC questionnaire
4 month
KOOS
Time Frame: 4 month
Differences between the to arms in the complete KOOS questionnaire.
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mikkel Lindegaard Attrup

Investigators

  • Principal Investigator: Mikkel Attrup, Artroscopic Center Amager

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

November 1, 2016

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (ESTIMATE)

December 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • meniskprojekt
  • H-4-2012-093 (OTHER: Committee on Health Research Ethics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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