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NCT03626038 · ClinicalTrials.gov registry record · NA
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
A NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by Zimmer Biomet.
- Active
- Registry status
- NA
- Development phase
- 135
- Enrollment target
- 7
- Study locations
NCT03626038: Active NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by Zimmer Biomet.
NCT03626038 is a NA study of Rheumatoid Arthritis and Osteoarthritis that is active but no longer recruiting, run by Zimmer Biomet. The registered enrollment target is 135 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03626038, a NA study of Rheumatoid Arthritis and Osteoarthritis, is active but no longer recruiting, sponsored by Zimmer Biomet.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE A.L.P.S. Proximal Humerus Plating System
Study Locations (7)
Seoul
- Korea University Anam Hospital - Seoul
- Hallym University Kangnam Sacred Hearth Hospital - Seoul
- Inje University Seoul Paik Hospital - Seoul
Florida
- Foundation for Orthopaedic Research & Education - Tampa
New South Wales
- Sydney Adventist Hospital - Wahroonga
Quebec
- The Research Institute of McGill University Health Centre - Montreal
Granges-Paccot
- Bone and Motion Training and Research Foundation - Granges-Paccot
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT03626038 still lists
NCT03626038 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which A.L.P.S. Proximal Humerus Plating System is the first listed.
NCT03626038 lists 7 locations in 5 states (Seoul, Florida, New South Wales).
Frequently Asked Questions
What is clinical trial NCT03626038 about?
NCT03626038 is a clinical study titled "Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System". 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.
What is the current status of trial NCT03626038?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 135 participants. The study started on 2018-06-19. Estimated completion is 2026-12.
What conditions does trial NCT03626038 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Osteoarthritis, Psoriatic Arthritis, Post Traumatic Arthritis, Proximal Humeral Fracture.
What interventions are being tested in trial NCT03626038?
The interventions under investigation include: A.L.P.S. Proximal Humerus Plating System (DEVICE).
Who is sponsoring clinical trial NCT03626038?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03626038 being conducted?
This trial has 7 study locations across Florida, New South Wales, Quebec, Seoul, Granges-Paccot. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03626038's enrollment target sits among peer trials
135 104th of 197 higher than 94 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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