Arthroscopic Rotator Cuff Reconstruction With or Without Biologic or Synthetic Patch Augmentation in Patients Over 60 Years: a Randomized Controlled Trial

Schulthess Klinik0 sitesJanuary 1, 2018

ConditionsRotator Cuff Tears

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rotator Cuff Tears
Sponsor: Schulthess Klinik
Primary Endpoint: Occurrence of retear
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.

Detailed Description

An arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. The primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.

Registry

clinicaltrials.gov

Start Date

January 1, 2018

End Date

January 1, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Schulthess Klinik

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Rotator cuff tear \> 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
•Indicated for surgical reconstruction by arthroscopy
•Patient aged 60 years and over
•Consenting participation in this study by signing the Informed Consent form

Exclusion Criteria

•Osteoarthritis (grade ≥ 2 after Samilson \& Prieto)
•Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
•Tear of the subscapularis \> Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
•Irreparable tear of the supraspinatus
•General medical contraindication to surgery
•Known hypersensitivity to the materials used
•Revision operations
•Open reconstruction
•Tendon transfer necessary (latissimus dorsi or pectoralis major)
•Any disease process that would preclude accurate evaluation including:

Outcomes

Primary Outcomes

Occurrence of retear

Time Frame: 24 months

Repair integrity will be assessed by an independent assessor on the basis of centralized MRI images.

Secondary Outcomes

Pain level (NRS)(6/24 months)
Range of motion (flexion, abduction, external and internal rotation)(6/24 months)
Shoulder strength in 90° abduction and in external rotation (0° abduction)(6/24 months)
Constant Murley Score (CS)(6/24 months)
Oxford Shoulder Score (OSS)(6/24 months)
Subjective shoulder value (SSV)(6/24 months)
Quality of life (utilities) and general health using EQ-5D-5L(6/24 months)
Subjective improvement, expectation, satisfaction with treatment(6/24 months)
Adverse events / complications(3/6/24 months and intra-operative)