Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

NCT ID: NCT02244788

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

Detailed Description

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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.

Conditions

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Arthroplasty of the PIP Joint

Interventions

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SR™ PIP

SR™ PIP

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Athanasian, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status AVAILABLE

Countries

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United States

Central Contacts

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Christian Victoria

Role: CONTACT

646-714-6640

Bridget Hayes, MHA, MPH

Role: CONTACT

212-774-2056

Facility Contacts

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Christian Victoria

Role: primary

646-714-6640

Bridget Hayes, MHA, MPH

Role: backup

212-774-2056

Other Identifiers

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2013-059

Identifier Type: -

Identifier Source: org_study_id

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