HUD: PIP Joint Implant

NCT ID: NCT02434913

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.)

Conditions

Arthrosis; Osteoarthrosis

Interventions

SR PIP Implant System

HUD for use in arthroplasty of the PIP joint

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with disability of the their finger from arthrosis

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hawkins Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Other Identifiers

Pro00026976

Identifier Type: -

Identifier Source: org_study_id