PMCF Study of the A.L.P.S. Proximal Humerus Plating System
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Psoriasis, Rheumatoid Arthritis |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/12/2018 |
| Start Date: | June 19, 2018 |
| End Date: | January 2021 |
| Contact: | Robert Barnhill |
| Email: | robert.barnhill@zimmerbiomet.com |
| Phone: | 574-377-9104 |
A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
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.
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.
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.
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.
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.
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