Trials / Terminated
TerminatedNCT03711591
Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
Proximal Humerus Fixation With the Conventus Cage™ PH Device A Post-Approval Observational Data Collection Study, A Single-Center Study, Memorial Hermann
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Conventus Orthopaedics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Conventus CAGE™ PH (PH Cage) System Post-Approval Observational Data Collection Study (Study) is a single center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.
Detailed description
The study is a prospective, non-randomized, post-market approval data collection study that is designed to collect device/procedure and outcome data on patients who have experienced proximal humerus bone fractures and received a PH Cage. Specifically, the study will provide: 1. Patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications. 2. Assurance of continued product safety and effectiveness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Conventus Cage PH device | The Conventus CAGE™ PH (PH Cage) is a permanent implant comprised of an expandable scaffold, made from nitinol and titanium, which is deployed into the medullary canal and provides a structure to which fractured bone fragments are attached using fragment screws. |
Timeline
- Start date
- 2018-11-29
- Primary completion
- 2020-02-17
- Completion
- 2020-02-17
- First posted
- 2018-10-18
- Last updated
- 2020-02-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03711591. Inclusion in this directory is not an endorsement.