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NCT03362320 Clinical Trial

Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03362320
Other study ID # SLvsDL
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 18, 2015
Est. completion date December 2022

Study information
Verified date July 2020
Source Austrian Research Group for Regenerative and Orthopedic Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date December 2022
Est. primary completion date February 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• double layer fixation

• single layer fixation

Locations
Country Name City State
Austria St. Vincent Shoulder & Sports Clinic Vienna

Sponsors (1)
Lead Sponsor Collaborator
Austrian Research Group for Regenerative and Orthopedic Medicine

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retear rate Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups 12 months postoperatively
Secondary 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
Secondary Range of motion (ROM) Comparison of ROMs between groups baseline, 24 and 60 months postoperatively
Secondary 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
Secondary VAS Comparison of the Visual Analogue Scale (VAS) between groups baseline, 24 and 60 months postoperatively
Secondary SST Comparison of the Simple Shoulder Test (SST) between groups baseline and 24 months postoperatively
Secondary 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
Secondary qDASH Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups baseline, 24 and 60 months postoperatively
Secondary WORC Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups baseline and 24 months postoperatively
Secondary SSV Comparison of the Simple Soulder Value (SSV) between groups baseline, 24 and 60 months postoperatively
Secondary SF-36 Comparison of the quality-of-life score short form 36 (SF-36) between groups baseline, 24 and 60 months postoperatively
Secondary Tendon integrity Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups baseline and 60 months postoperatively
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