Status: Enrolling by invitation
Keywords: Hand, , PIP Joint , PIP Arthroplasty , PIP Pyrocarbon Implant
IRB Number: 00017900
Specialty: Orthopaedic Surgery, Orthopaedic Surgery
Sub Specialties: Congenital Hand, Hand Surgery
It is my intention, after your approval to use the Ascension PIP joint in patients with indications consistent with the FDA approved Indications. As part of the requirements of an HDE approval, reports will be made immediately to the IRB in the event of serious complications and adverse events, and a yearly report will be provided to the IRB outlining number of patients treated and any adverse events. In summary, candidates for surgery will be chosen by Dr. Hutchinson. These candidates will likely present to clinic with arthritis of the PIP joint. Options will be discussed and should this surgical option be chosen, measures will be taken to provide the patient with PIP arthroplasty utilizing the Ascension PIP pyrocarbon implant (surgical technique is attached).