Clinical trial NCT04825249: A New Modified Suture Bridge Technique
Official title: A New Modified Suture Bridge Technique for Medium-sized Rotator Cuff Tears: Functional and Radiological Outcomes of a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: rotator cuff tear， modified suture bridge technique
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.

Detailed description: Purpose: We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.

Methods: We prospectively followed 50 consecutive patients with medium rotator cuff tears treated with the modified suture bridge (MSB) or traditional suture bridge technique (TSB) from December 2018 and December 2019. On the basis of preoperative findings and MRI performance, 26 patients underwent MSB repair whereas 24 underwent TSB repair. Range of shoulder motion, visual analog scale score (VAS score), University of California-Los Angeles score (UCLA score), Constant-Murley shoulder score (Constant score), American Shoulder and Elbow Surgeons score (ASES score) were assessed. Magnetic resonance imaging were performed preoperatively and at 12 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* (1) full-thickness medium tears (1-3cm) of primary supraspinatus (SSP) tendon was identified on preoperative MRI and intraoperative arthroscopy, (2) undesirable conservative treatment for 3 months, (3)completed follow-up of 12 months postoperatively and patients who adhered to the rehabilitation plan.

Exclusion Criteria:

* (1) previous shoulder surgery, (2) Other pathological changes that would need to be addressed at the time of arthroscopic surgery, such as rotator cuff tear involving the subscapular (SSC) tendon，biceps tendon injury, (3) failure to follow our postoperative rehabilitation protocol and patients without regular follow-up.

Primary outcomes:
measure: Cuff integrity grade of MRI assessment
timeFrame: at 12 months postoperatively
measure: Muscle atrophy grade of MRI assessment
timeFrame: at 12 months postoperatively
measure: Fatty degeneration grade of MRI assessment
timeFrame: at 12 months postoperatively
measure: Range of shoulder motion
timeFrame: at 12 months postoperatively
measure: The Visual Analog Scale score
timeFrame: preoperatively
measure: The Visual Analog Scale score
timeFrame: at 12 months postoperatively
measure: University of California-Los Angeles score
timeFrame: preoperatively
measure: University of California-Los Angeles score
timeFrame: at 12 months postoperatively
Secondary outcomes:
measure: Constant-Murray Shoulder score
timeFrame: preoperatively
measure: Constant-Murray Shoulder score
timeFrame: at 12 months postoperatively
measure: American Shoulder and Elbow Surgeon score
timeFrame: preoperatively
measure: American Shoulder and Elbow Surgeon score
timeFrame: at 12 months postoperatively
Other outcomes:
Locations:
city: Shangdong
country: China
facility: The Affiliated Hospital of Qingdao University
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Tengbo Yu
role: STUDY_DIRECTOR
References:
citation: Takeuchi Y, Sugaya H, Takahashi N, Matsuki K, Tokai M, Morioka T, Ueda Y, Hoshika S. Repair Integrity and Retear Pattern After Arthroscopic Medial Knot-Tying After Suture-Bridge Lateral Row Rotator Cuff Repair. Am J Sports Med. 2020 Aug;48(10):2510-2517. doi: 10.1177/0363546520934786. Epub 2020 Jul 14.
citation: Kim KC, Shin HD, Lee WY, Yeon KW, Han SC. Clinical outcomes and repair integrity of arthroscopic rotator cuff repair using suture-bridge technique with or without medial tying: prospective comparative study. J Orthop Surg Res. 2018 Aug 28;13(1):212. doi: 10.1186/s13018-018-0921-z.
citation: Dukan R, Ledinot P, Donadio J, Boyer P. Arthroscopic Rotator Cuff Repair With a Knotless Suture Bridge Technique: Functional and Radiological Outcomes After a Minimum Follow-Up of 5 Years. Arthroscopy. 2019 Jul;35(7):2003-2011. doi: 10.1016/j.arthro.2019.02.028. Epub 2019 May 27.