HUD: PIP Joint Implant
Primary Purpose
Arthrosis, Osteoarthrosis
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
SR PIP Implant System
Sponsored by
About this trial
This is an expanded access trial for Arthrosis focused on measuring Proximal interphalangeal joint deformity, Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Patients with disability of the their finger from arthrosis
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02434913
First Posted
September 15, 2014
Last Updated
February 20, 2018
Sponsor
The Hawkins Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02434913
Brief Title
HUD: PIP Joint Implant
Official Title
HUD: Proximal Interphalangeal (PIP) Joint Implant Finger Prosthesis
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
4. Oversight
5. Study Description
Brief 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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthrosis, Osteoarthrosis
Keywords
Proximal interphalangeal joint deformity, Arthroplasty
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SR PIP Implant System
Intervention Description
HUD for use in arthroplasty of the PIP joint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Eligibility Criteria
Inclusion Criteria:
Patients with disability of the their finger from arthrosis
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Allen, MD
Organizational Affiliation
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
HUD: PIP Joint Implant
We'll reach out to this number within 24 hrs