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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Re-operation — 1 year Re--operation within the first year post-initial surgery due to screw perforation of the humeral head, secondary displacement or impingement to relieve pain and/or improve function.
Trial sites (7)
Facility
City
Region
Status
Foundation for Orthopaedic Research & Education
Tampa
Florida
Sydney Adventist Hospital
Wahroonga
New South Wales
The Research Institute of McGill University Health Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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