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First received: May 25, 2023

Clinical Trial: Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Rotator Cuff Tear

Study Type: OBSERVATIONAL


Official Title: Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch.

Brief Summary: This is a clinical investigation study.It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions.The medical device in this study is already on the market and is manufactured by Xiros Ltd.The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm).It is reinforced around the perimeter and around each eyelet to provide strength and…

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