Trials / Active Not Recruiting
Active Not RecruitingNCT03626038
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Osteoarthritis
- Rheumatoid Arthritis
- Post-Traumatic Arthritis
- Psoriatic Arthritis
- Proximal Humeral Fracture
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-06-19
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2018-08-10
- Last updated
- 2026-02-13
Locations
7 sites across 5 countries: United States, Australia, Canada, South Korea, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03626038. Inclusion in this directory is not an endorsement.