NCT02244775

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

First QC Date

September 12, 2014

Last Update Submit

September 18, 2014

Conditions

Keywords

osteo-arthritispost traumatic arthritis

Interventions

SR™MCPDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 19, 2014

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations