Zimmer Biomet’s RAISE Study: A Game-Changer in Shoulder Arthroplasty?

Zimmer Biomet Holdings ((ZBH)) announced an update on their ongoing clinical study.

Study Overview: The study titled ‘A Multi-Center, Prospective Post-Market Clinical Follow-Up Study: Subscapularis Repair Augmented With Tapestry Biointegrative Implant After Shoulder Arthroplasty Evaluation (RAISE)’ aims to assess the long-term integrity of subscapularis tendon repair post shoulder arthroplasty. Conducted by Zimmer Biomet, its primary focus is on evaluating the tendon repair’s integrity using ultrasound six months post-surgery, alongside secondary objectives like assessing shoulder function, safety, and patient-reported outcomes.

Intervention/Treatment: The study tests the Tapestry Biointegrative Implant, a collagen-based device designed to serve as a protective layer between the tendon and surrounding tissues. This implant is intended to enhance the repair of the subscapularis tendon by promoting tissue integration.

Study Design: This observational study follows a prospective, case-only model. Participants are evaluated at multiple intervals: preoperatively, during surgery, and at 3, 6, 12, and 24 months post-surgery, focusing on the primary purpose of assessing tendon repair integrity.

Study Timeline: The study began on February 6, 2023, with an estimated completion date of June 27, 2025. These dates are crucial as they guide the timeline for data collection and subsequent analysis, impacting the study’s contribution to clinical practices.

Market Implications: This study could significantly influence Zimmer Biomet’s market position by validating the effectiveness of the Tapestry Biointegrative Implant. Positive outcomes may boost investor confidence and enhance stock performance. The study’s findings could also set a benchmark for competitors in the orthopedic implant industry, potentially reshaping market dynamics.

The study is currently ongoing, with further details available on the ClinicalTrials portal.