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NCT Number: NCT05624164

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

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.

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Key information

Conditions

Rotator Cuff Tears Fractures, Bone Fractures, Stress Micro Fracture Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nantong University, Nantong, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lateralised microfracture

Procedure

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

Primary outcomes

  1. Magnetic Resonance Imaging (MRI)

    Time frame: 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

Secondary outcomes

  1. Active range of motion of Shoulder

    Time frame: Preoperative, 3 months and 24 months postoperative

    Active forward flexion, abduction and external rotation will be measured with a manual goniometer at the preoperative visit, 3 months and 24 months after surgery.

  2. Passive range of motion of Shoulder

    Time frame: Preoperative, 3 months and 24 months postoperative

    Passive forward flexion, abduction and external rotation will be measured with a manual goniometer at the preoperative visit, 3 months and 24 months after surgery.

  3. American Shoulder and Elbow Score

    Time frame: Preoperative, 3 months and 24 months postoperative

    American Shoulder and Elbow scores (minimum 0 points, maximum 100 points, higher values are considered better outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months and 24 months after surgery.

  4. University at California at Los Angeles Shouder Rating Scale

    Time frame: Preoperative, 3 months and 24 months postoperative

    University at California at Los Angeles Shoulder Rating Scale(minimum 3 points, maximum 35 points, higher values are considered better outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months and 24 months after surgery.

  5. Visual Analog Scale for Pain

    Time frame: Preoperative, 3 months and 24 months postoperative

    Visual Analog Scale for Pain(minimum 0 points, maximum 10 points, higher values are considered worse outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months, and 24 months after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingbing Xiao, Ph.D

CONTACT

[email protected]

+86051381162222

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 22, 2022
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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