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Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362320
Recruitment Status : Active, not recruiting
First Posted : December 5, 2017
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Philipp Heuberer, Austrian Research Group for Regenerative and Orthopedic Medicine

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: double layer fixation Procedure: single layer fixation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome
Actual Study Start Date : June 18, 2015
Actual Primary Completion Date : February 28, 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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



Primary Outcome Measures :
  1. Retear rate [ Time Frame: 12 months postoperatively ]
    Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups


Secondary Outcome Measures :
  1. Constant-Murley score [ Time Frame: baseline, 24 and 60 months postoperatively ]
    Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups

  2. Range of motion (ROM) [ Time Frame: baseline, 24 and 60 months postoperatively ]
    Comparison of ROMs between groups

  3. Satisfaction with the procedure [ Time Frame: 24 and 60 months postoperatively ]
    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').

  4. VAS [ Time Frame: baseline, 24 and 60 months postoperatively ]
    Comparison of the Visual Analogue Scale (VAS) between groups

  5. SST [ Time Frame: baseline and 24 months postoperatively ]
    Comparison of the Simple Shoulder Test (SST) between groups

  6. ASES [ Time Frame: baseline, 24 and 60 months postoperatively ]
    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.

  7. qDASH [ Time Frame: baseline, 24 and 60 months postoperatively ]
    Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups

  8. WORC [ Time Frame: baseline and 24 months postoperatively ]
    Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups

  9. SSV [ Time Frame: baseline, 24 and 60 months postoperatively ]
    Comparison of the Simple Soulder Value (SSV) between groups

  10. SF-36 [ Time Frame: baseline, 24 and 60 months postoperatively ]
    Comparison of the quality-of-life score short form 36 (SF-36) between groups

  11. Tendon integrity [ Time Frame: baseline and 60 months postoperatively ]
    Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362320


Locations
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Austria
St. Vincent Shoulder & Sports Clinic
Vienna, Austria
Sponsors and Collaborators
Austrian Research Group for Regenerative and Orthopedic Medicine
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philipp Heuberer, Principal Investigator, Austrian Research Group for Regenerative and Orthopedic Medicine
ClinicalTrials.gov Identifier: NCT03362320    
Other Study ID Numbers: SLvsDL
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries