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

Rupture; Meniscus, Bucket Handle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01740232
• Other study ID #: meniskprojekt
• Secondary ID: H-4-2012-093
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2012
• Last updated: January 14, 2015
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: January 2015
• Source: Amager Hospital
• Contact: Mikkel Attrup
• Phone: +4531494239
• Email: mikkel.attrup[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rupture; Meniscus, Bucket Handle

Intervention

Procedure:
• trephination
Artroscopic meniskal repair with trephination.
• Normal meniscal repair
Artroscopic meniskal repair without trephination.

Locations

Country	Name	City	State
Denmark	Artroskopisk Center Amager	Copenhagen
Denmark	Artroskopisk Center Amager	Copenhagen S	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mikkel Lindegaard Attrup

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lysholm	Lysholm questionnaire	4 month	Yes
Other	rearthroscopy		6 month	Yes
Other	KOOS	Differences between the to arms in the complete KOOS questionnaire.	12 month	Yes
Other	Lysholm	Lysholm questionnaire	12 month	Yes
Other	IKDC	IKDC questionnaire	12 month	Yes
Other	IKDC	IKDC questionnaire	4 month	Yes
Other	KOOS	Differences between the to arms in the complete KOOS questionnaire.	4 month	Yes
Primary	KOOS Questionnaire	Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.	4 month	Yes
Primary	KOOS Questionnaire	Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.	12 month	Yes
Secondary	Clinical meniscus healing		4 month	Yes