NCT03626038

Brief 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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
5 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jun 2018Dec 2026

Study Start

First participant enrolled

June 19, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

8.5 years

First QC Date

July 23, 2018

Last Update Submit

February 10, 2026

Conditions

Post-Traumatic ArthritisPsoriatic ArthritisOsteoarthritisRheumatoid ArthritisProximal Humeral Fracture

Keywords

TraumaMedical DevicePerformanceSafetyProximal Humeral Fracture

Outcome Measures

Primary Outcomes (1)

  • Re-operation

    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 Outcomes (3)

  • Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire

    2 years

  • Shoulder range of motion measurement

    2 years

  • Clinical performance of the device is assessed using x-ray capture

    2 years

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Foundation for Orthopaedic Research & Education

Tampa, Florida, 33637, United States

Location

Sydney Adventist Hospital

Wahroonga, New South Wales, 2076, Australia

Location

The Research Institute of McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Korea University Anam Hospital

Seoul, Seoul, 02841, South Korea

Location

Hallym University Kangnam Sacred Hearth Hospital

Seoul, Seoul, 07441, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, Seoul, 07441, South Korea

Location

Bone and Motion Training and Research Foundation

Granges-Paccot, Granges-Paccot, 1763, Switzerland

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidArthritis, PsoriaticShoulder FracturesWounds and Injuries

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesFractures, BoneShoulder Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 10, 2018

Study Start

June 19, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)AU(1)CA(1)US(1)CH(1)