Clinical trial NCT04686968: Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Microfractures
Keywords: rotator cuff tear
Microfractures
greenhouse
Suture Bridge Technique
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: American Shoulder and Elbow Surgeons Shoulder (ASES) score
timeFrame: 1 year postoperatively
measure: American Shoulder and Elbow Surgeons Shoulder (ASES) score
timeFrame: 2 years postoperatively
measure: tendon integrity
timeFrame: 1 year postoperatively
measure: Visual Analogue Scale(VAS)
timeFrame: 1 year postoperatively
measure: Visual Analogue Scale(VAS)
timeFrame: 2 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sports Medicine Service, Beijing Jishuitan hospital
name: Chunyan Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.