Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Wi… (NCT03511547) | Clinical Trial Compass
WithdrawnNot Applicable
Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.
Stopped: Personal reasons
0Started 2018-01-01
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
* Inadequate blood flow or neuromuscular disease in the affected arm
* Recent history of substance abuse
* Legal incompetence
* German language barrier to complete the questionnaires or
* Participation in any other medical device or medicinal product study that could influence the results of the present study