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

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ClinicalTrials.gov Identifier: NCT01740232
Recruitment Status : Unknown
Verified January 2015 by Mikkel Lindegaard Attrup, Amager Hospital.
Recruitment status was:  Recruiting
First Posted : December 4, 2012
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Mikkel Lindegaard Attrup, Amager Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rupture; Meniscus, Bucket Handle Procedure: trephination Procedure: Normal meniscal repair Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone
Study Start Date : November 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

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 Name: Normal meniscal suture with FastFix device.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Clinical meniscus healing [ Time Frame: 4 month ]

Other Outcome Measures:
  1. Lysholm [ Time Frame: 4 month ]
    Lysholm questionnaire

  2. rearthroscopy [ Time Frame: 6 month ]
  3. KOOS [ Time Frame: 12 month ]
    Differences between the to arms in the complete KOOS questionnaire.

  4. Lysholm [ Time Frame: 12 month ]
    Lysholm questionnaire

  5. IKDC [ Time Frame: 12 month ]
    IKDC questionnaire

  6. IKDC [ Time Frame: 4 month ]
    IKDC questionnaire

  7. KOOS [ Time Frame: 4 month ]
    Differences between the to arms in the complete KOOS questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740232


Contacts
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Contact: Mikkel Attrup +4531494239 mikkel.attrup@regionh.dk

Locations
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Denmark
Artroskopisk Center Amager Recruiting
Copenhagen S, Copenhagen, Denmark, 2300
Contact: Mikkel Attrup    +45 32 34 32 90    mikkel.attrup@regionH.dk   
Principal Investigator: Mikkel Attrup         
Artroskopisk Center Amager Not yet recruiting
Copenhagen, Denmark, 2300
Contact: Mikkel Attrup    +45 31494239    mikkel.attrup@regionh.dk   
Principal Investigator: Mikkel Attrup         
Sponsors and Collaborators
Mikkel Lindegaard Attrup
Investigators
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Principal Investigator: Mikkel Attrup Artroscopic Center Amager
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Responsible Party: Mikkel Lindegaard Attrup, Staff Specialist 1, Amager Hospital
ClinicalTrials.gov Identifier: NCT01740232    
Other Study ID Numbers: meniskprojekt
H-4-2012-093 ( Other Identifier: Committee on Health Research Ethics )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries