Clinical trial NCT03609164: Does the Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?
Official title: Does the Arthroscopic Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: arthroscopic surgery
massive rotator cuff repair
single-row repair
suture-spanning augmentation
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in applying double-row repair, suture cutting through the tendon, too much tension over the repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may increase the healing over tendon bone junction as well as decrease the risk of anchors loosening. A suture-spanning augmentation with two set of suture loops passing over musculotendinous junction medially and fixed with anchor at the lateral cortical wall may solve the problem. In order to define the clinical benefit of this adjuvant procedure, a prospective randomized control study is designed to compare the adjunctive reinforce suture with the single-row simple suture repair in massive rotator cuff tear.

Around sixty patients were randomized divided into two groups. The study group was used adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2 separated set of transverse looping sutures over the medial musculotendinous junction in addition to single row repair, while the control group was used single row repair technique in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.

If the suture-spanning augmentation of single-row repair can yield an improved healing rate and fewer complications, massive rotator cuff tear should be repaired earlier in order to prevent the late development of irreparable tear.


Eligibility criteria: Inclusion Criteria:

* the pre-operative image (MRI) showing the massive rotator cuff tear (fulfilling one of the following definition a tear with a diameter of 5 cm or more; a complete tear of two or more tendons; one with a coronal length and sagittal width greater than or equal to 2 cm)
* patient was willing and able to provide scores for the study

Exclusion Criteria:

* irreparable rotator cuff tear which was identified pre-operatively or intra-operatively
* glenohumeral or acromioclavicular joint osteoarthritis
* stage III or more of the fatty degenerative of supraspinatus in Goutallier classification
* revision surgery
* patients with bacteremia, a systemic infection, or an infection at the surgical site
* patients who previously attempted or failed a treatment program

Primary outcomes:
measure: Retear rate
timeFrame: 6 months
Secondary outcomes:
measure: Visual Analog Score (VAS)
timeFrame: 2 years
measure: The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: 2 years
measure: University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)
timeFrame: 2 years
measure: Shoulder constant score
timeFrame: 2 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Hsiao-Li
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Hsiao-Li Ma, MD
role: STUDY_DIRECTOR
References:
citation: Ma HH, Chen KH, Chiang ER, Chou TA, Ma HL. Does Arthroscopic Suture-Spanning Augmentation of Single-Row Repair Reduce the Retear Rate of Massive Rotator Cuff Tear? Am J Sports Med. 2019 May;47(6):1420-1426. doi: 10.1177/0363546519836419. Epub 2019 Apr 18.