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Clinical Trials in South Korea / NCT03626038
Active, not recruiting Not applicable

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

NCT03626038 · tracked via the Priya Life Science South Korea tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2018-06-19
Last updated
2026-02-13

Condition(s) studied

OsteoarthritisRheumatoid ArthritisPost-Traumatic ArthritisPsoriatic ArthritisProximal Humeral Fracture

Investigational drug(s) / intervention(s)

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

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.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Re-operation — 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.

Trial sites (7)

FacilityCityRegionStatus
Foundation for Orthopaedic Research & Education Tampa Florida
Sydney Adventist Hospital Wahroonga New South Wales
The Research Institute of McGill University Health Centre Montreal Quebec
Korea University Anam Hospital Seoul Seoul
Hallym University Kangnam Sacred Hearth Hospital Seoul Seoul
Inje University Seoul Paik Hospital Seoul Seoul
Bone and Motion Training and Research Foundation Granges-Paccot Granges-Paccot

More Zimmer Biomet trials in South Korea

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G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture Active, not recruiting
Comprehensive Nano - Post Market Clinical Follow-Up Study Active, not recruiting

Other trials for the same condition

Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage Active, not recruiting
G7 Dual Mobility With Vivacit-E or Longevity PMCF Enrolling by invitation
A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis Recruiting
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy Active, not recruiting
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03626038 on ClinicalTrials.gov ↗ ← All trials in South Korea