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

NCT ID: NCT04686968

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rotator Cuff Tears Microfractures

Keywords

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rotator cuff tear Microfractures greenhouse Suture Bridge Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Greenhouse Technique

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Microfracture Combined With Suture Bridge Technique

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Jiang

Director of Sports Medicine Service of Beijing Jishuitan hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunyan Jiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sports Medicine Service, Beijing Jishuitan hospital

Central Contacts

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Zhijun Zhang, M.D.

Role: CONTACT

Phone: +86 15201277648

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 23522987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32976717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25487905 (View on PubMed)

Other Identifiers

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CJiang-Greenhouse

Identifier Type: -

Identifier Source: org_study_id