Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
NCT03626038 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135
Last updated 2026-02-13
Summary
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.
Conditions
- Osteoarthritis
- Rheumatoid Arthritis
- Post-Traumatic Arthritis
- Psoriatic Arthritis
- Proximal Humeral Fracture
Interventions
- DEVICE
-
A.L.P.S. Proximal Humerus Plating System
Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients.
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-19
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
- Australia
- Canada
- South Korea
- Switzerland
Study Locations
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