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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000057 / PAS001 |
| Date Original Protocol Accepted |
11/19/2001
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| Date Current Protocol Accepted |
09/10/2018
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| Study Name |
Ascension MCPT
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| Device Name |
ASCENSION MCP
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension MCP prosthesis.
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| Study Population |
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
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| Sample Size |
100 patients from 4 clinical sites
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| Key Study Endpoints |
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.
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| Follow-up Visits and Length of Follow-up |
surgery/immediate post-op, 6 weeks, 12 weeks, 6 months, and 12 months
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| 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.
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| 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.
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| Patient Follow-up Rate |
The average follow-up well exceeded the 1-year requirement in the CoA in a majority of the articles included.
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| 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).
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| 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).
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| 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.
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