Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries

Sponsor

Beijing Jishuitan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04686968

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears Microfractures	Procedure: Greenhouse Technique Procedure: Microfracture Combined With Suture Bridge Technique	N/A

Detailed Description

Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in the Treatment of Medium-sized Full-thickness Rotator Cuff Injuries: A Prospective Randomized Controlled Study

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Greenhouse group Patients underwent greenhouse technique：The high-strength suture was passed through the tendon using Mason-Allen method, and then Crimson duvet procedure was performed on the foot print area from the articular surface of the humeral head to the apex of the greater tubercle. Immediately after this procedure, a lateral row anchor was used.	Procedure: Greenhouse Technique First, the high-strength sutures were passed through the teared tendon, and then Crimson duvet procedure was performed on the footprint from the articular margin of the humeral head to the apex of the greater tubercle, followed by a lateral row anchor.
Active Comparator: Vent group The three-line anchor suture method is the same as before, the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.	Procedure: Microfracture Combined With Suture Bridge Technique A three-line anchor suture method is used as in the greenhouse technique, except that the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.

Arm

Intervention/Treatment

Experimental: Greenhouse group

Patients underwent greenhouse technique：The high-strength suture was passed through the tendon using Mason-Allen method, and then Crimson duvet procedure was performed on the foot print area from the articular surface of the humeral head to the apex of the greater tubercle. Immediately after this procedure, a lateral row anchor was used.

Procedure: Greenhouse Technique

First, the high-strength sutures were passed through the teared tendon, and then Crimson duvet procedure was performed on the footprint from the articular margin of the humeral head to the apex of the greater tubercle, followed by a lateral row anchor.

Active Comparator: Vent group

The three-line anchor suture method is the same as before, the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.

Procedure: Microfracture Combined With Suture Bridge Technique

A three-line anchor suture method is used as in the greenhouse technique, except that the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.

Outcome Measures

Primary Outcome Measures

American Shoulder and Elbow Surgeons Shoulder (ASES) score [1 year postoperatively]
A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
American Shoulder and Elbow Surgeons Shoulder (ASES) score [2 years postoperatively]
A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
tendon integrity [1 year postoperatively]
MRI was used to assess the integrity of the repaired rotator cuff tendon
Visual Analogue Scale(VAS) [1 year postoperatively]
A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
Visual Analogue Scale(VAS) [2 year postoperatively]
A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy
Between 20-65 years old

Exclusion Criteria:

Bilateral rotator cuff tear
Underwent ipsilateral surgery
Large-to-massive rotator cuff tear
Combined with Bankart, SLAP or AC lesion
Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration