NCT02097901

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

March 17, 2014

Last Update Submit

January 27, 2017

Conditions

Rupture of the Rotator Cuff

Keywords

Rotator CuffInjuryRepairMicrofractureHealing

Outcome Measures

Primary Outcomes (2)

  • Change in Western Ontario Rotator Cuff Index (WORC)

    Standardized questionnaire

    0, 3 and 12 months

  • Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)

    Standardized questionnaire

    0, 3 and 12 months

Secondary Outcomes (1)

  • MRI integrity of the rotatorcuff

    12 months

Other Outcomes (3)

  • Strength of rotatorcuff

    3 and 12 months

  • Function of rotatorcuff

    3 and 12 months

  • Complications

    12 months

Study Arms (2)

Microfracture

EXPERIMENTAL

Rotator Cuff Repair AND Microfracture at rotatorcuff footprint

Procedure: Microfracture

NO microfracture

ACTIVE COMPARATOR

Rotator cuff reinsertion without microfracture

Procedure: NO microfracture

Interventions

MicrofracturePROCEDURE

Rotator Cuff Repair AND Microfracture

Microfracture
NO microfracturePROCEDURE

Rotator Cuff Repair without microfracture

NO microfracture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge Sygehus

Køge, Lykkebækvej 1, 4600, Denmark

Location

MeSH Terms

Conditions

Wounds and InjuriesFractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, Bone

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 27, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

DK(1)