Microfracture in Rotator Cuff Injury Repair

Zealand University Hospital

Status: Suspended

Conditions: Rupture of the Rotator Cuff

Treatments: Procedure: NO microfracture; Procedure: Microfracture

Study type: Interventional

Funder types: Other

Identifiers

NCT02097901

SJ-370

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Microfracture

Experimental group

Description:

Rotator Cuff Repair AND Microfracture at rotatorcuff footprint

Treatment:

Procedure: Microfracture

NO microfracture

Active Comparator group

Description:

Rotator cuff reinsertion without microfracture

Treatment:

Procedure: NO microfracture