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

February 10, 2026 updated by: Zimmer Biomet

A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wahroonga, New South Wales, Australia, 2076
        • Sydney Adventist Hospital
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • The Research Institute of McGill University Health Centre
  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul, South Korea, 07441
        • Hallym University Kangnam Sacred Hearth Hospital
      • Seoul, Seoul, South Korea, 07441
        • Inje University Seoul Paik Hospital
  • Switzerland
    • Granges-Paccot
      • Granges-Paccot, Granges-Paccot, Switzerland, 1763
        • Bone and Motion Training and Research Foundation
  • United States
    • Florida
      • Tampa, Florida, United States, 33637
        • Foundation for Orthopaedic Research & Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients who receive the A.L.P.S. Prox. Humerus Plating Sys.

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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-operation
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire
Time Frame: 2 years
Pain, function and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0 to 100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
2 years
Shoulder range of motion measurement
Time Frame: 2 years
Shoulder range of motion is assessed in degrees of directional movement. This will be measured during a physical exam by the investigator. Values measured include active and passive range of motion.
2 years
Clinical performance of the device is assessed using x-ray capture
Time Frame: 2 years
X-ray capture will be used to analyze fracture healing
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMG2017-59T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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