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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears; Microfractures
• Intervention / Treatment: Procedure: Greenhouse Technique; Procedure: Microfracture Combined With Suture Bridge Technique

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Principal Investigator: Chunyan Jiang, M.D., Sports Medicine Service, Beijing Jishuitan hospital

Publications and helpful links

General Publications

• Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.
• Kim C, Lee YJ, Kim SJ, Yoon TH, Chun YM. Bone Marrow Stimulation in Arthroscopic Repair for Large to Massive Rotator Cuff Tears With Incomplete Footprint Coverage. Am J Sports Med. 2020 Nov;48(13):3322-3327. doi: 10.1177/0363546520959314. Epub 2020 Sep 25.
• Taniguchi N, Suenaga N, Oizumi N, Miyoshi N, Yamaguchi H, Inoue K, Chosa E. Bone marrow stimulation at the footprint of arthroscopic surface-holding repair advances cuff repair integrity. J Shoulder Elbow Surg. 2015 Jun;24(6):860-6. doi: 10.1016/j.jse.2014.09.031. Epub 2014 Dec 2.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: rotator cuff tear; Microfractures; greenhouse; Suture Bridge Technique
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Fractures, Stress
• Other Study ID Numbers: CJiang-Greenhouse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No