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

Last updated: December 13, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Psoriatic Arthritis

Treatment

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

Clinical Study ID

NCT03626038
CMG2017-59T
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patient must be 18 years of age or older.

  • Patient must have a primary proximal humerus fracture (Orthopaedic TraumaAssociation/ American Orthopedic 11-A, B, C) requiring surgical intervention and beeligible 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 approvedinformed consent.

  • Patient must be in a good nutritional state

Exclusion

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 informedconsent and/or participation in follow-up program.

  • Patient has an active infection.

  • Patient conditions including limitations in blood supply, obesity, or insufficientquantity or quality of bone stock.

  • Patient is sensitive to foreign body material.

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: A.L.P.S. Proximal Humerus Plating System
Phase:
Study Start date:
June 19, 2018
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Sydney Adventist Hospital

    Wahroonga, New South Wales 2076
    Australia

    Site Not Available

  • The Research Institute of McGill University Health Centre

    Montréal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Hallym University Kangnam Sacred Hearth Hospital

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • Inje University Seoul Paik Hospital

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Bone and Motion Training and Research Foundation

    Granges-Paccot, 1763
    Switzerland

    Site Not Available

  • Foundation for Orthopaedic Research & Education

    Tampa, Florida 33637
    United States

    Site Not Available

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