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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Ascension MCPT


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General
Study Status Progress Inadequate
Application Number P000057 / PAS001
Date Current Protocol Accepted 02/08/2002
Study Name OSB Lead-Ascension MCPT
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension MCP prosthesis.
Study Population Description This device is indicated for use as a total joint replacement of index, long, ring, and small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus,

osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization. The study Inclusion Criteria: Patients who have all of the following characteristics are eligible for inclusion: - Index, long, ring, or small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e. subluxation/dislocation) secondary to articular destruction or degenerative disease related-to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis; or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization - Willing to participate in the study - Signed an Informed Consent Form - The means and ability to return for all required study visits Exclusion Criteria: Patients who have any of the following contraindications will be excluded from the study: - Inadequate bone stock at the implantation site - Active infection in the MCP joint - Nonfunctioning and irreparable MCP musculotendinous system - Physical interference with or by other prostheses during implantation or use - Procedures requiring modification of the prosthesis - Skin, bone, circulatory and/or neurological deficiency at the implantation site
Sample Size 100 patients from 4 clinical sites
Data Collection Data endpoints include: - MCP range of motion (ROM) - MCP joint ulnar deviation - Pinch and grip strength - Implanted related joint pain - Patient satisfaction - Radiographic appearance (subsidence, migration, and peri-prosthetic bone changes) - Joint position (reduced, subluxed or dislocated) - Complications, adverse events, and post-op procedures.
Follow-up Visits and Length of Follow-up surgery/immediate post-op, 6 weeks, 12 weeks, 6 months, and 12 months


OSB Lead-Ascension MCPT Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Annual Report 11/14/2007 11/14/2007 On Time
7 year report 11/17/2008 12/17/2008 Overdue/Received
8 year report 11/17/2009 11/19/2009 Overdue/Received
enrollment update report/9 year 05/17/2010 02/14/2011 Overdue/Received
10 year report 11/17/2011 12/19/2011 Overdue/Received
yearly report 11/19/2012 11/21/2012 Overdue/Received
12 year report 11/21/2013 02/28/2014 Overdue/Received
13 year report 11/21/2014 11/05/2014 On Time
14 year report 11/05/2015 11/19/2015 Overdue/Received
15 year report 11/05/2016 02/27/2017 Overdue/Received
16 year report 11/05/2017   Overdue


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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