Clinical trial NCT03183466: Do You Arthroscopic Repair for Subscapularis Tendon Tear, Which Accounts for More Than Half of the 1st Facet? Or do You Perform Debridement?
Official title: Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Subscapularis Tendon Tear More Than 1/2 to Entire 1st Facet (Representing 1/3 to More Than 1/3 Tear of Subscapularis Entire Footprint)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subscapularis Tendon Tear
Arthroscopic Repair
Arthroscopic Debridement
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.

Detailed description: The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.

Eligibility criteria: Inclusion Criteria:

* Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope
* Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm)
* Combined biceps lesion
* Combined acromial clavicle (AC) arthritis

Exclusion Criteria:

* Revision case or previous surgical history of the index shoulder
* Any open surgery, including open repair of the subscapularis tendon
* Compensation case
* Combined severe arthritis of the glenohumeral joint
* Patient who selects one's own surgical method, i.e. not randomized
* Infection, tumor, etc

Primary outcomes:
measure: Range of Motion (ROM)
timeFrame: 2 year postoperatively
measure: Pain Visual Analogue Scale (PVAS)
timeFrame: 2 year postoperatively
measure: American Shoulder and Elbow Surgeons' score
timeFrame: 2 year postoperatively
measure: Constant score
timeFrame: 2 year postoperatively
measure: Korean Shoulder Score (KSS) score
timeFrame: 2 year postoperatively
Secondary outcomes:
measure: repair integrity analysis using postoperative MRI
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Burkhart SS, Tehrany AM. Arthroscopic subscapularis tendon repair: Technique and preliminary results. Arthroscopy. 2002 May-Jun;18(5):454-63. doi: 10.1053/jars.2002.30648.
citation: Denard PJ, Jiwani AZ, Ladermann A, Burkhart SS. Long-term outcome of a consecutive series of subscapularis tendon tears repaired arthroscopically. Arthroscopy. 2012 Nov;28(11):1587-91. doi: 10.1016/j.arthro.2012.02.031. Epub 2012 May 24.
citation: Flury MP, John M, Goldhahn J, Schwyzer HK, Simmen BR. Rupture of the subscapularis tendon (isolated or in combination with supraspinatus tear): when is a repair indicated? J Shoulder Elbow Surg. 2006 Nov-Dec;15(6):659-64. doi: 10.1016/j.jse.2005.07.013. Epub 2006 Oct 19.