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Microfracture in Rotator Cuff Injury Repair

Primary Purpose

Rupture of the Rotator Cuff

Status
Suspended
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Microfracture
NO microfracture
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of the Rotator Cuff focused on measuring Rotator Cuff, Injury, Repair, Microfracture, Healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients over the age of 18 with a full thickness rotatorcuff rupture.

Exclusion Criteria:

  • Isolated rupture of the subscapularis
  • Tendon atrophia
  • Goutallier grade 3-4 fatty degeneration
  • Fracture surgery in same shoulder
  • Inflammatory or neurologic affection of shoulder
  • Other disabling disease
  • Unwilling to participate in study

Sites / Locations

  • Køge Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Microfracture

NO microfracture

Arm Description

Rotator Cuff Repair AND Microfracture at rotatorcuff footprint

Rotator cuff reinsertion without microfracture

Outcomes

Primary Outcome Measures

Change in Western Ontario Rotator Cuff Index (WORC)
Standardized questionnaire
Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Standardized questionnaire

Secondary Outcome Measures

MRI integrity of the rotatorcuff
Intact rotatorcuff Partial rupture Full thickness rupture

Full Information

First Posted
March 17, 2014
Last Updated
January 27, 2017
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02097901
Brief Title
Microfracture in Rotator Cuff Injury Repair
Official Title
Microfracture in Rotator Cuff Injury Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Suspended
Why Stopped
Insufficient patient material
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of the Rotator Cuff
Keywords
Rotator Cuff, Injury, Repair, Microfracture, Healing

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
Microfracture
Arm Type
Experimental
Arm Description
Rotator Cuff Repair AND Microfracture at rotatorcuff footprint
Arm Title
NO microfracture
Arm Type
Active Comparator
Arm Description
Rotator cuff reinsertion without microfracture
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
Rotator Cuff Repair AND Microfracture
Intervention Type
Procedure
Intervention Name(s)
NO microfracture
Intervention Description
Rotator Cuff Repair without microfracture
Primary Outcome Measure Information:
Title
Change in Western Ontario Rotator Cuff Index (WORC)
Description
Standardized questionnaire
Time Frame
0, 3 and 12 months
Title
Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Description
Standardized questionnaire
Time Frame
0, 3 and 12 months
Secondary Outcome Measure Information:
Title
MRI integrity of the rotatorcuff
Description
Intact rotatorcuff Partial rupture Full thickness rupture
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Strength of rotatorcuff
Description
Strength 0-5 in abduction and external rotation.
Time Frame
3 and 12 months
Title
Function of rotatorcuff
Description
Range of movement in abduction and external rotation in full degrees.
Time Frame
3 and 12 months
Title
Complications
Description
Assesses the complication rate in each group such as infection, bleeding and reoperation.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients over the age of 18 with a full thickness rotatorcuff rupture. Exclusion Criteria: Isolated rupture of the subscapularis Tendon atrophia Goutallier grade 3-4 fatty degeneration Fracture surgery in same shoulder Inflammatory or neurologic affection of shoulder Other disabling disease Unwilling to participate in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Blønd, M.D
Organizational Affiliation
Køge Sygehus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gunner S Barfoed, M.D
Organizational Affiliation
Køge Sygehus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas JN Sørensen, M.D
Organizational Affiliation
Køge Sygehus
Official's Role
Study Director
Facility Information:
Facility Name
Køge Sygehus
City
Køge
State/Province
Lykkebækvej 1
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

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Microfracture in Rotator Cuff Injury Repair

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