A.L.P.S. Plating System for Shoulder Fracture

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Zimmer Biomet

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.

Research Team

Kacy Arnold, RN MBA

Principal Investigator

Zimmer Biomet

Eligibility Criteria

This trial is for adults over 18 with a fresh shoulder fracture needing surgery, who can follow the study's procedures and are in good health. It's not for those with delayed surgery, mental conditions preventing consent, current substance abuse, active infections, poor bone quality or blood supply issues, sensitivity to foreign materials, prisoners or tumor-related fractures.

Inclusion Criteria

Patient must be able and willing to complete the protocol required follow-up.

I need surgery for a major shoulder fracture and can be treated with plates and screws.

My non-surgical treatment failed within 3 weeks of my injury.

Exclusion Criteria

Patient is a prisoner.

My surgery has been postponed for over 3 weeks.

You have a sensitivity to foreign objects.

Treatment Details

Interventions

• A.L.P.S. Proximal Humerus Plating System (Orthopedic Implant)

Trial Overview The A.L.P.S. Proximal Humerus Plating System is being tested for safety and performance in treating shoulder fractures. This multicenter study involves patients getting this specific plate-and-screw fixation treatment without randomization or control groups.

Participant Groups

Group I: Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. Experimental Treatment 1 Intervention

Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System. Subjects can be enrolled prospectively or retrospectively as indicated in the protocol.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business