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

Active Not RecruitingNA

Sponsor: Zimmer Biomet

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

Interventions: A.L.P.S. Proximal Humerus Plating System

Countries: United States, Australia, Canada, South Korea, Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Locations (7)

Tampa, Florida, United States
Wahroonga, New South Wales, Australia
Montreal, Quebec, Canada
Seoul, Seoul, South Korea
Seoul, Seoul, South Korea
Seoul, Seoul, South Korea
Granges-Paccot, Granges-Paccot, Switzerland