Microfracture in Rotator Cuff Injury Repair

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02097901

Enrollment

100

Registered

2014-03-27

Start date

2014-03-31

Completion date

2018-03-31

Last updated

2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of the Rotator Cuff

Keywords

Rotator Cuff, Injury, Repair, Microfracture, Healing

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.

Interventions

PROCEDUREMicrofracture

Rotator Cuff Repair AND Microfracture

PROCEDURENO microfracture

Rotator Cuff Repair without microfracture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
MRI integrity of the rotatorcuff	12 months	* Intact rotatorcuff * Partial rupture * Full thickness rupture

Other

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026