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

NCT04686968 | Unknown

• 1 other identifier: CJiang-Greenhouse
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tears; Microfractures

Keywords

rotator cuff tear; Microfractures; greenhouse; Suture Bridge Technique

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Greenhouse group

EXPERIMENTAL

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

Vent group

ACTIVE COMPARATOR

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

Interventions

Greenhouse Technique PROCEDURE

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.

Greenhouse group

Microfracture Combined With Suture Bridge Technique PROCEDURE

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.

Vent group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Related Publications (3)

• 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.

  PMID: 23522987 BACKGROUND

• 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.

  PMID: 32976717 BACKGROUND

• 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.

  PMID: 25487905 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Fractures, Stress

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Fractures, Bone

Study Officials

• Chunyan Jiang, M.D.

  Sports Medicine Service, Beijing Jishuitan hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijun Zhang, M.D.

CONTACT

+86 15201277648; zzj5285029@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sports Medicine Service of Beijing Jishuitan hospital

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 29, 2020
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share