Trials / Completed
CompletedNCT02983292
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 137 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity.
Detailed description
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty. 137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PyroTITAN™ HRA | Humeral Resurfacing |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2023-02-08
- Completion
- 2023-02-08
- First posted
- 2016-12-06
- Last updated
- 2024-11-04
- Results posted
- 2024-11-04
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT02983292. Inclusion in this directory is not an endorsement.