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

  • STATUS
    Recruiting
  • days left to enroll
    20
  • participants needed
    135
  • sponsor
    Zimmer Biomet
Updated on 23 April 2022
conservative management
conservative therapy
fracture treatment
conservative treatment
humeral fracture

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.

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.

Details
Condition Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Psoriatic Arthritis, Proximal Humeral Fracture
Treatment A.L.P.S. Proximal Humerus Plating System
Clinical Study IdentifierNCT03626038
SponsorZimmer Biomet
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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