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Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02244775
Enrollment
Unknown
Registered
2014-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty of the MCP Joint

Keywords

osteo-arthritis, post traumatic arthritis

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.

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.

Interventions

DEVICESR™MCP

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* patient is in need of a revision of failed MCP prosthesis(es) * 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

* patient is not in need of a revision of a failed MCP prothesis(es) * patient is eligible to use an alternative implant

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026