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

Rotator Cuff Tears Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04686968
• Other study ID #: CJiang-Greenhouse
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: July 2024

Study information

• Verified date: December 2020
• Source: Beijing Jishuitan Hospital
• Contact: Zhijun Zhang, M.D.
• Phone: +86 15201277648
• Email: zzj5285029[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Stress
• Microfractures
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	tendon integrity	MRI was used to assess the integrity of the repaired rotator cuff tendon	1 year postoperatively
Primary	Visual Analogue Scale(VAS)	A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome	1 year postoperatively
Primary	Visual Analogue Scale(VAS)	A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome	2 year postoperatively