Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: double layer fixation; Procedure: single layer fixation

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • St. Vincent Shoulder & Sports Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: double layer fixation; Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation	Procedure: double layer fixation
Experimental: single layer fixation; Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation	Procedure: single layer fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retear rate	Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley score	Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups	baseline, 24 and 60 months postoperatively
Range of motion (ROM)	Comparison of ROMs between groups	baseline, 24 and 60 months postoperatively
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').	24 and 60 months postoperatively
VAS	Comparison of the Visual Analogue Scale (VAS) between groups	baseline, 24 and 60 months postoperatively
SST	Comparison of the Simple Shoulder Test (SST) between groups	baseline and 24 months postoperatively
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.	baseline, 24 and 60 months postoperatively
qDASH	Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups	baseline, 24 and 60 months postoperatively
WORC	Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups	baseline and 24 months postoperatively
SSV	Comparison of the Simple Soulder Value (SSV) between groups	baseline, 24 and 60 months postoperatively
SF-36	Comparison of the quality-of-life score short form 36 (SF-36) between groups	baseline, 24 and 60 months postoperatively
Tendon integrity	Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups	baseline and 60 months postoperatively

Collaborators and Investigators

• Sponsor: Austrian Research Group for Regenerative and Orthopedic Medicine
• Investigators: Study Director: Werner Anderl, MD, Austrian Research Group for Regenerative and Orthopedic Medicine; Principal Investigator: Philipp R Heuberer, MD, Austrian Research Group for Regenerative and Orthopedic Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2015
• Primary Completion (Actual): February 28, 2017
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 11, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: SLvsDL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No