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NCT02434913 Clinical Trial

HUD: PIP Joint Implant

Osteoarthrosis Clinical Trial

Official title:
HUD: Proximal Interphalangeal (PIP) Joint Implant Finger Prosthesis

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02434913
Other study ID # Pro00026976
Secondary ID
Status No longer available
Phase N/A
First received September 15, 2014
Last updated February 20, 2018

Study information
Verified date February 2018
Source The Hawkins Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This surgery involves the use of a finger joint replacement device for treatment of patients with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who expect to place their hands in heavy loading situations, or patients needing revision of a failed implant placed in the PIP joint. A joint replacement surgery is an operation where the arthritic joint is removed and a metal and plastic joint is inserted to replace the natural joint. The surgery is expected to last about 2 hours. The procedure is done in the operating room and requires general anesthesia or an axillary block. (General anesthesia affects the entire body and is accompanied by a loss of consciousness. An axillary block results in anesthesia of the hand and forearm only. A tourniquet is applied to the arm to prevent bleeding during the surgery.)

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Patients with disability of the their finger from arthrosis

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SR PIP Implant System
HUD for use in arthroplasty of the PIP joint

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Hawkins Foundation
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