Microfracture in Rotator Cuff Injury Repair

January 27, 2017 updated by: Morten S. Wad, Zealand University Hospital
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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
    • Lykkebækvej 1
      • Køge, Lykkebækvej 1, Denmark, 4600
        • Køge Sygehus

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microfracture
Rotator Cuff Repair AND Microfracture at rotatorcuff footprint
Procedure: Microfracture
Rotator Cuff Repair AND Microfracture
Active Comparator: NO microfracture
Rotator cuff reinsertion without microfracture
Procedure: NO microfracture
Rotator Cuff Repair without microfracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Western Ontario Rotator Cuff Index (WORC)
Time Frame: 0, 3 and 12 months
Standardized questionnaire
0, 3 and 12 months
Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Time Frame: 0, 3 and 12 months
Standardized questionnaire
0, 3 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI integrity of the rotatorcuff
Time Frame: 12 months
  • Intact rotatorcuff
  • Partial rupture
  • Full thickness rupture
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength of rotatorcuff
Time Frame: 3 and 12 months
Strength 0-5 in abduction and external rotation.
3 and 12 months
Function of rotatorcuff
Time Frame: 3 and 12 months
Range of movement in abduction and external rotation in full degrees.
3 and 12 months
Complications
Time Frame: 12 months
Assesses the complication rate in each group such as infection, bleeding and reoperation.
12 months

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Investigators

  • Study Director: Lars Blønd, M.D, Køge Sygehus
  • Study Director: Gunner S Barfoed, M.D, Køge Sygehus
  • Study Director: Thomas JN Sørensen, M.D, Køge Sygehus

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

March 1, 2014

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-370

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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