Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Micro Fracture; Rotator Cuff Tears

Treatments: Procedure: Lateralised microfracture

Study type: Interventional

Funder types: Other

Identifiers

NCT05624164

micorfracture

Details and patient eligibility

About

The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are:

• [whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.]
• [whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI
2. Patients can complete the follow-up and comply with all post-operative rehab instructions
3. Failure of non-operative treatment for at least 3 months

Exclusion criteria

1. Revision rotator cuff surgery
2. Partial thickness rotator cuff tears
3. Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears
4. Disease history of the affected shoulder
5. Systemic immune diseases
6. Irreparable rotator cuff tear

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Lateralized microfracture group

Experimental group

Description:

Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair with microfracture at the lateral side of the footprint immediately.

Treatment:

Procedure: Lateralised microfracture

No microfracture group

No Intervention group

Description:

Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair without microfracture.