Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint



Status:Available
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Contact:Sophia Paul, BA
Email:pauls@hss.edu
Phone:212-774-2440

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The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal
Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a
requirement by the FDA for humanitarian use of device

The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™
PIP (Proximal Interphalangeal) Implants. This is NOT a research study, but rather, a
requirement by the FDA for humanitarian use of device. Use of the SR™ PIP is approved for
humanitarian use by the FDA when either the patient is in need of a revision of failed PIP
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 PIP joint.

Inclusion Criteria:

- patient is in need of a revision of failed PIP 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
PIP joint

Exclusion Criteria:

- patient is not in need of a revision of a failed PIP prothesis(es)

- patient is eligible to use an alternative implant
We found this trial at
1
site
535 E 70th St
New York, New York 10021
(212) 606-1000
Phone: 212-774-2440
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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mi
from
New York, NY
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