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

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lateralised microfracture

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring rotator cuff tear, microfracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Affiliated Hospital of Nantong University
Afiliated Hospital of Nantong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lateralized microfracture group

No microfracture group

Arm 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.

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

Outcomes

Primary Outcome Measures

Magnetic Resonance Imaging (MRI)

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 Outcome Measures

Active range of motion of Shoulder

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.

Passive range of motion of Shoulder

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.

American Shoulder and Elbow Score

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.

University at California at Los Angeles Shouder Rating Scale

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.

Visual Analog Scale for Pain

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.

Full Information

NCT ID

NCT05624164

First Posted

October 30, 2022

Last Updated

November 17, 2022

Sponsor

Affiliated Hospital of Nantong University

1. Study Identification

Unique Protocol Identification Number

NCT05624164

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Affiliated Hospital of Nantong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears, Micro Fracture

Keywords

rotator cuff tear, microfracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lateralized microfracture group

Arm Type

Experimental

Arm 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.

Arm Title

No microfracture group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Lateralised microfracture

Intervention Description

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

Primary Outcome Measure Information:

Title

Magnetic Resonance Imaging (MRI)

Description

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

Time Frame

24 months postoperative

Secondary Outcome Measure Information:

Title

Active range of motion of Shoulder

Description

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.

Time Frame