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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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Ascension MCPT


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General
Study Status Progress Adequate
Application Number P000057 / PAS001
Date Current Protocol Accepted 09/10/2018
Study Name 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
Interim or Final Data Summary
Actual Number of Patients Enrolled Overall, 259 joints reported in literature were replaced with the pyrocarbon MCP devices within the period since pre-market approval of this device till the end of August 2017.
Actual Number of Sites Enrolled This literature review is based on an analysis of available articles containing post-market clinical data relevant to the intended purpose of the Integra Ascension MCP implant, including clinical performance and safety data. The device is evaluated for safety and efficacy, based on data available from the published scientific literature. The scientific literature included in this review is the result of a literature search that covered the period between 19 November 2001 (date of FDA approval of the device) and 28 August 2017 and yielded 12 scientific publications included in the analysis.
Patient Follow-up Rate The average follow-up well exceeded the 1-year requirement in the CoA in a majority of the articles included.
Final Safety Findings Adverse Events

There were no serious adverse events reported in this scientific literature review that lead to death, birth defect, life-threatening injury/illness, prolonged hospitalization, or permanent impairment of body.

There was a 1.9% incidence of joint deformity (including ulnar deviation/drift), a 5.4% incidence of implant subluxation or dislocation, an 8.5% incidence of device revision or removal, a 5% incidence of other soft tissue reoperations, and a 0.4% incidence of synovitis. In sum, there was a 12.7% occurrence of adverse events and an 8.5% rate of revision.

Device Revisions

There was an 8.5% (22/259) incidence of device revision across the twelve articles identified in this systematic literature review. There were a variety of reasons for device revisions and removals. One device was removed and one revised due to chronic pain (Parker et al. 2006; Wagner et al. 2015). Tendon complications such as contracture and adhesion caused 4 device revisions and 2 removals in Petscavage et al (2011). There were 6 revisions to rectify subluxation, dislocation or instability (Parker et al. 2007; Wagner et al. 2015). Dickson et al (2015) reported 6 revisions for dislocation, fracture and loosening. Finally, two patients underwent device revision surgeries due to dissatisfaction with results, one patient experienced limited range of motion and the other felt his precision pinch had diminished after surgery (Wall & Stern, 2013; Simpson-White and Chojnowski, 2013).
Final Effect Findings Patient Reported Outcome

¿ Patient Satisfaction

Seven of the studies (123 patients) reviewed reported patient satisfaction rates. Patient satisfaction rates ranged between 89% to 100% and most patients said they would elect to have the surgery again.

¿ Pain Reduction

Three studies (59 patients, 127 procedures) reported preoperative and postoperative Visual Analog Scale (VAS) pain scores. The patients in these studies showed an 86% alleviation of pain symptoms, from an average VAS score of 61.4 to an average score of 6.8. The OA patients of Parker et al (2006) had a preoperative average VAS pain score of 73.1 which fell to 8.5 postoperatively. The RA patients of Parker et al (2007) had an average preoperative VAS pain score of 43 which fell to 9 postoperatively. Nunez & Citron (2005) did not perform a statistical comparison of pre- and post-operative pain scores, but did show a decrease in reported pain, from an average VAS score of 68 preoperatively to 3 at the postoperative examination.

Objective Measurement

¿ Improvement in Mechanical Measures

Eleven studies (242 procedures) reported mechanical outcomes of Integra Ascension MCP arthroplasty, as measured by grip strength, pinch strength or range of motion. In summary, across these trials, there was an average 20.3% increase in grip strength (4.7 kg), an average 20.2% increase in arc range of motion (6.3°) and an average 184% increase in oppositional pinch strength (3.8 kg).

Device Survival

Device survival is defined as the number of devices that remain in patients treated with Integra Ascension MCP devices, at follow-up. All twelve of the publications included in the scientific literature review presented data on device removals and revisions. Average survival at follow-up examination was 95% at 1-year, 93% at 2-years, 85% at 5-years (please note that not all studies reached 5-year follow-up time point).
Study Strengths & Weaknesses The strength of this literature review is that it includes several articles documenting long-term patient reported outcomes especially subjective pain and patient satisfaction, both of which showed preferable results. Additionally, the average follow-up was higher than what was required in the original approval order. Most studies in this literature review did not have a universal method for post-operation rehabilitation, which can be considered as a study weakness, but because we have seen a good patient satisfaction rate based on this literature review, we think this lack of universal post-op rehab method does not impact our assessment significantly.


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


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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