Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System

Running, not enrolling · Not applicable

Conditions studied: Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Psoriatic Arthritis, Proximal Humeral Fracture

In brief

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.

Key facts

Study ID

NCT03626038

Run by

Zimmer Biomet

People needed

135

Starts

2018-06-19

Expected to finish

2026-12-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be 18 years of age or older.
• Patient must have a primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws.
• Patients with failed conservative treatment within 3 weeks since injury.
• Patient must be able and willing to complete the protocol required follow-up.
• Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent.
• Patient must be in a good nutritional state

You may not qualify if…

• Delay of surgery for more than 3 weeks.
• Tumor induced fractures
• Patient is a prisoner.
• Pregnancy/ breast feeding
• Patient is a current alcohol or drug abuser.
• Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program.
• Patient has an active infection.
• Patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock.
• Patient is sensitive to foreign body material.

Where it is running

• Foundation for Orthopaedic Research & Education — Tampa, Florida, United States
• Sydney Adventist Hospital — Wahroonga, New South Wales, Australia
• The Research Institute of McGill University Health Centre — Montreal, Quebec, Canada
• Korea University Anam Hospital — Seoul, Seoul, South Korea
• Hallym University Kangnam Sacred Hearth Hospital — Seoul, Seoul, South Korea
• Inje University Seoul Paik Hospital — Seoul, Seoul, South Korea
• Bone and Motion Training and Research Foundation — Granges-Paccot, Granges-Paccot, Switzerland

Full record on ClinicalTrials.gov

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