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

Zimmer Biomet

Status: Enrolling

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

Treatments: Device: A.L.P.S. Proximal Humerus Plating System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03626038

CMG2017-59T

Details and patient eligibility

About

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.

Full description

The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. Proximal Humerus Plating System is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation.

A minimum of 7 and maximum of 10 sites globally will be involved in this study. This number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. Each site will be allowed to enroll 27 humeri. Enrollment is competitive. All potential study subjects will be required to participate in the Informed Consent process.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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135 participants in 1 patient group

Patients who receive the A.L.P.S. Prox. Humerus Plating Sys.

Experimental group

Description:

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.

Treatment:

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