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Recruiting Not applicable

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

NCT05624164 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2022-10-01
Last updated
2022-11-22

Condition(s) studied

Rotator Cuff TearsMicro Fracture

Investigational drug(s) / intervention(s)

Lateralised microfracture

Lateralised microfracture: making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Magnetic Resonance Imaging (MRI) — 24 months postoperative
    The scans were evaluated for rotator cuff integrity and degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist

Trial sites (2)

FacilityCityRegionStatus
Affiliated Hospital of Nantong University Nantong Jiangsu Not Yet Recruiting
Afiliated Hospital of Nantong University Nantong Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05624164 on ClinicalTrials.gov ↗ ← All trials in China