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Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

Primary Purpose

Rotator Cuff Tear

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
double layer fixation
single layer fixation
Sponsored by
Austrian Research Group for Regenerative and Orthopedic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

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

Inclusion Criteria:

  • patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation
  • tear size of at least 2.5 cm and up to 4.0 cm
  • signed informed consent

Exclusion Criteria:

  • axillary nerve palsy

Sites / Locations

  • St. Vincent Shoulder & Sports Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

double layer fixation

single layer fixation

Arm Description

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation

Outcomes

Primary Outcome Measures

Retear rate
Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups

Secondary Outcome Measures

Constant-Murley score
Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups
Range of motion (ROM)
Comparison of ROMs between groups
Satisfaction with the procedure
Comparison of satisfaction with the procedure between groups. Satisfaction is evaluated by asking patients one question to rate their satisfaction with the procedure based on a likert scale (4 = 'very satisfied', 3 = 'quite satisfied', 2 = 'moderately satisfied', 1 = 'less satisfied', 0 = 'not at all satisfied').
VAS
Comparison of the Visual Analogue Scale (VAS) between groups
SST
Comparison of the Simple Shoulder Test (SST) between groups
ASES
Comparison of the American Shoulder and Elbow Surgeons score (ASES) between groups. The ASES is a patient-rated questionnaire with a total between 0 and 100 points with higher scores indicating better outcome.
qDASH
Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups
WORC
Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups
SSV
Comparison of the Simple Soulder Value (SSV) between groups
SF-36
Comparison of the quality-of-life score short form 36 (SF-36) between groups
Tendon integrity
Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups

Full Information

First Posted
November 16, 2017
Last Updated
July 11, 2020
Sponsor
Austrian Research Group for Regenerative and Orthopedic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03362320
Brief Title
Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation
Official Title
A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2015 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Austrian Research Group for Regenerative and Orthopedic Medicine

4. Oversight

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

5. Study Description

Brief Summary
Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
double layer fixation
Arm Type
Experimental
Arm Description
Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation
Arm Title
single layer fixation
Arm Type
Experimental
Arm Description
Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation
Intervention Type
Procedure
Intervention Name(s)
double layer fixation
Intervention Type
Procedure
Intervention Name(s)
single layer fixation
Primary Outcome Measure Information:
Title
Retear rate
Description
Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
Constant-Murley score
Description
Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups
Time Frame
baseline, 24 and 60 months postoperatively
Title
Range of motion (ROM)
Description
Comparison of ROMs between groups
Time Frame
baseline, 24 and 60 months postoperatively
Title
Satisfaction with the procedure
Description
Comparison of satisfaction with the procedure between groups. Satisfaction is evaluated by asking patients one question to rate their satisfaction with the procedure based on a likert scale (4 = 'very satisfied', 3 = 'quite satisfied', 2 = 'moderately satisfied', 1 = 'less satisfied', 0 = 'not at all satisfied').
Time Frame
24 and 60 months postoperatively
Title
VAS
Description
Comparison of the Visual Analogue Scale (VAS) between groups
Time Frame
baseline, 24 and 60 months postoperatively
Title
SST
Description
Comparison of the Simple Shoulder Test (SST) between groups
Time Frame
baseline and 24 months postoperatively
Title
ASES
Description
Comparison of the American Shoulder and Elbow Surgeons score (ASES) between groups. The ASES is a patient-rated questionnaire with a total between 0 and 100 points with higher scores indicating better outcome.
Time Frame
baseline, 24 and 60 months postoperatively
Title
qDASH
Description
Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups
Time Frame
baseline, 24 and 60 months postoperatively
Title
WORC
Description
Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups
Time Frame
baseline and 24 months postoperatively
Title
SSV
Description
Comparison of the Simple Soulder Value (SSV) between groups
Time Frame
baseline, 24 and 60 months postoperatively
Title
SF-36
Description
Comparison of the quality-of-life score short form 36 (SF-36) between groups
Time Frame
baseline, 24 and 60 months postoperatively
Title
Tendon integrity
Description
Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups
Time Frame
baseline and 60 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation tear size of at least 2.5 cm and up to 4.0 cm signed informed consent Exclusion Criteria: axillary nerve palsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Anderl, MD
Organizational Affiliation
Austrian Research Group for Regenerative and Orthopedic Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Philipp R Heuberer, MD
Organizational Affiliation
Austrian Research Group for Regenerative and Orthopedic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent Shoulder & Sports Clinic
City
Vienna
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
31917608
Citation
Heuberer PR, Pauzenberger L, Gruber MS, Ostermann RC, Hexel M, Laky B, Anderl W. Delaminated Rotator Cuff Tears Showed Lower Short-term Retear Rates After Arthroscopic Double-Layer Repair Versus Bursal Layer-Only Repair: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):689-696. doi: 10.1177/0363546519897033. Epub 2020 Jan 9.
Results Reference
derived

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Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

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