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

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Suture-bridge augmentation of single-row repair
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring arthroscopic surgery, massive rotator cuff repair, single-row repair, suture-spanning augmentation

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hsiao-Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Suture-spanning augmentation of single-row repair

single-row repair

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analog Score (VAS)
Record the VAS (pain level from 0-10) by the questionnaire, pre-op/post-op 2-year
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Record the ASES score by the questionnaire, focus on joint pain, instability, and activities of daily living, pre-op/post-op 2year
University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)
Record the UCLA shoulder score by the questionnaire, focusing on five sub-scales made up of: active forward elevation and strength (physician reported), pain, satisfaction, and function (patient reported), pre-op/post-op 2-year
Shoulder constant score
Record the shoulder constant score by the questionnaire, focusing on ROM, functional assessment, strength measure, pre-op/post-op 2-year

Full Information

First Posted
July 17, 2018
Last Updated
July 24, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03609164
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
arthroscopic surgery, massive rotator cuff repair, single-row repair, suture-spanning augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suture-spanning augmentation of single-row repair
Arm Type
Experimental
Arm Title
single-row repair
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Suture-bridge augmentation of single-row repair
Primary Outcome Measure Information:
Title
Retear rate
Description
Using MR imaging to determine the presence or absence of rotator cuff retears
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Visual Analog Score (VAS)
Description
Record the VAS (pain level from 0-10) by the questionnaire, pre-op/post-op 2-year
Time Frame
2 years
Title
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Description
Record the ASES score by the questionnaire, focus on joint pain, instability, and activities of daily living, pre-op/post-op 2year
Time Frame
2 years
Title
University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)
Description
Record the UCLA shoulder score by the questionnaire, focusing on five sub-scales made up of: active forward elevation and strength (physician reported), pain, satisfaction, and function (patient reported), pre-op/post-op 2-year
Time Frame
2 years
Title
Shoulder constant score
Description
Record the shoulder constant score by the questionnaire, focusing on ROM, functional assessment, strength measure, pre-op/post-op 2-year
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Li Ma, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Hsiao-Li
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30998402
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.
Results Reference
derived

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

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