Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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patient is in need of a revision of failed MCP prosthesis(es)
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patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint
Exclusion Criteria:
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patient is not in need of a revision of a failed MCP prothesis(es)
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patient is eligible to use an alternative implant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital for Special Surgery | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Hospital for Special Surgery, New York
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013-090