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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02244775
Expanded Access Status : Approved for marketing
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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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
Arthroplasty of the MCP Joint Device: SR™MCP

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
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Study Type : Expanded Access
Official Title: Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

Resource links provided by the National Library of Medicine


Interventions
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244775


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
More Information
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02244775    
Other Study ID Numbers: 2013-090
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Hospital for Special Surgery, New York:
osteo-arthritis
post traumatic arthritis