NCT03511547

Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Schulthess Klinik · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DEVICE	Pitch Patch	The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ \[PP\]) augmentation.
DEVICE	ArthroFlex	The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® \[AF\]) augmentation.

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2018-04-30
• Last updated: 2020-10-22