NCT03626038Active, not recruiting
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 135 (actual)
- First submitted
- 23 Jul 2018
- Start date
- 19 Jun 2018
- Primary completion date
- Dec 2026
- Lead sponsor
- Zimmer Biomet
- Diseases
- Psoriasis, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT03626038
What you commit to
- Study type: Interventional
- Participants enrolled: 135
- From 19 Jun 2018 to the primary completion date, Dec 2026
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Delay of surgery for more than 3 weeks.
- Patient is a current alcohol or drug abuser.
Other illness
- 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.
Other
- Tumor induced fractures
- Patient is a prisoner.
- Pregnancy/ breast feeding
- Patient is sensitive to foreign body material.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sydney Adventist Hospital Coordinator of this site? Confirm its status | Wahroonga | Australia | Unknown status |
| The Research Institute of McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Bone and Motion Training and Research Foundation Coordinator of this site? Confirm its status | Granges-Paccot | Switzerland | Unknown status |
| Inje University Seoul Paik Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hallym University Kangnam Sacred Hearth Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Foundation for Orthopaedic Research & Education Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.