Trials / Approved For Marketing
Approved For MarketingNCT02244775
Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Hospital for Special Surgery, New York · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The purpose of this study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device.
Detailed description
The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ MCP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed MCP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SR™MCP |
Timeline
- First posted
- 2014-09-19
- Last updated
- 2014-09-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02244775. Inclusion in this directory is not an endorsement.