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

Sponsor
Affiliated Hospital of Nantong University
Study ID
NCT05624164
Status
Recruiting
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Conditions

  • Micro Fracture
  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Nov 22, 2022
Start date
Oct 1, 2022
Status verified
Aug 2022
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lateralized microfracture group
    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.
  • No Intervention: No microfracture group
    Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair without microfracture.

Primary Outcome Measure

Magnetic Resonance Imaging (MRI) [ Time Frame: 24 months postoperative ]

Central Contacts

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