search
Back to results

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

Primary Purpose

Rupture; Meniscus, Bucket Handle

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
trephination
Normal meniscal repair
Sponsored by
Mikkel Lindegaard Attrup
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture; Meniscus, Bucket Handle

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Artroskopisk Center AmagerRecruiting
  • Artroskopisk Center Amager

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Trephination

Normal meniscal repair

Arm Description

A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair.

standard operation. Normal meniscalrepair.

Outcomes

Primary Outcome Measures

KOOS Questionnaire
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
KOOS Questionnaire
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

Clinical meniscus healing

Full Information

First Posted
October 12, 2012
Last Updated
January 14, 2015
Sponsor
Mikkel Lindegaard Attrup
search

1. Study Identification

Unique Protocol Identification Number
NCT01740232
Brief Title
Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?
Official Title
A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mikkel Lindegaard Attrup

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture; Meniscus, Bucket Handle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trephination
Arm Type
Active Comparator
Arm Description
A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair.
Arm Title
Normal meniscal repair
Arm Type
Placebo Comparator
Arm Description
standard operation. Normal meniscalrepair.
Intervention Type
Procedure
Intervention Name(s)
trephination
Intervention Description
Artroscopic meniskal repair with trephination.
Intervention Type
Procedure
Intervention Name(s)
Normal meniscal repair
Other Intervention Name(s)
Normal meniscal suture with FastFix device.
Intervention Description
Artroscopic meniskal repair without trephination.
Primary Outcome Measure Information:
Title
KOOS Questionnaire
Description
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
Time Frame
4 month
Title
KOOS Questionnaire
Description
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Clinical meniscus healing
Time Frame
4 month
Other Pre-specified Outcome Measures:
Title
Lysholm
Description
Lysholm questionnaire
Time Frame
4 month
Title
rearthroscopy
Time Frame
6 month
Title
KOOS
Description
Differences between the to arms in the complete KOOS questionnaire.
Time Frame
12 month
Title
Lysholm
Description
Lysholm questionnaire
Time Frame
12 month
Title
IKDC
Description
IKDC questionnaire
Time Frame
12 month
Title
IKDC
Description
IKDC questionnaire
Time Frame
4 month
Title
KOOS
Description
Differences between the to arms in the complete KOOS questionnaire.
Time Frame
4 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikkel Attrup
Phone
+4531494239
Email
mikkel.attrup@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Attrup
Organizational Affiliation
Artroscopic Center Amager
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artroskopisk Center Amager
City
Copenhagen S
State/Province
Copenhagen
ZIP/Postal Code
2300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkel Attrup
Phone
+45 32 34 32 90
Email
mikkel.attrup@regionH.dk
First Name & Middle Initial & Last Name & Degree
Mikkel Attrup
Facility Name
Artroskopisk Center Amager
City
Copenhagen
ZIP/Postal Code
2300
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkel Attrup
Phone
+45 31494239
Email
mikkel.attrup@regionh.dk
First Name & Middle Initial & Last Name & Degree
Mikkel Attrup

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs