Does the Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?

NCT03609164 | Completed

• 1 other identifier: 104-2314-B-075-082
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

arthroscopic surgery; massive rotator cuff repair; single-row repair; suture-spanning augmentation

Outcome Measures

Primary Outcomes (1)

• Retear rate

  Using MR imaging to determine the presence or absence of rotator cuff retears

  6 months

Secondary Outcomes (4)

• Visual Analog Score (VAS)

  2 years

• The American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  2 years

• University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)

  2 years

• Shoulder constant score

  2 years

Study Arms (2)

Suture-spanning augmentation of single-row repair

EXPERIMENTAL

Procedure: Suture-bridge augmentation of single-row repair

single-row repair

ACTIVE COMPARATOR

Procedure: Suture-bridge augmentation of single-row repair

Interventions

Suture-bridge augmentation of single-row repair PROCEDURE

Suture-spanning augmentation of single-row repair; single-row repair

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Hsiao-Li

Taipei, 11217, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30998402 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Hsiao-Li Ma, MD

  Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 1, 2018
• Study Start: May 1, 2015
• Primary Completion: April 30, 2016
• Study Completion: June 30, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)