Integra Ascension MCP Manual Del Usario página 3

These adverse effects may lead to additional surgery and could result in:
• implant removal
• joint fusion
• amputation
• death
Clinical Case Studies
The Ascension MCP device described in section 1, Device Description, is a
modifi cation to an earlier version of the device that was used in the clinical
case series (summarized below) . For clarity, the earlier device design is
designated as the "Pyrocarbon MCP . " The results of pre-clinical testing
demonstrated that the design and materials of the Pyrocarbon MCP implant
were similar to the Ascension MCP implant . Therefore, the following clinical
data for the Pyrocarbon MCP implant was provided to support a deter-
mination that the Ascension MCP implant is safe and effective .
Objective and Design
Between 1979 and 1987, a total of 151 Pyrocarbon MCP finger joint devices
were implanted in 53 patients at the Mayo Clinic, Rochester Minnesota, USA
by Drs . Beckenbaugh and Linscheid . Of these, 147 implants were primary ball-
and-cup, uncemented, Pyrocarbon MCP implants; 2 were condylar
pyrocarbon implants (implants with a conical shaped bump in the center of
the articulating surface of the distal component that interfaced with a groove
on the proximal componentʼs articu lating surface); and 2 were revision ball-
and-cup Pyrocarbon MCP implants (one uncemented and one cemented) . The
53 patients who received the 147 primary ball-and-cup uncemented
Pyrocarbon MCP implants represent the case series upon which the clinical
data in this PMA is based .
A retrospective case series analysis of the 53 patients who received the 147
primary, ball-and-cup, uncemented, Pyrocarbon MCP total joint implants was
reviewed to evaluate the safety and effectiveness of the Ascension MCP
implant . In this retrospective case history review, 53 patients received 147
Pyrocarbon MCP prostheses and the last patient evaluation was at an average
of 8 . 5 years (range 1 . 7 months – 17 . 2 years) after implantation . Case histories
for the study population were reviewed and information used to evaluate
device safety and effectiveness was gathered . An independent contract
research organization (CRO) audited and validated the accuracy and
completeness of the case history records . The CRO entered information into a
computerized database, and analyzed the data to determine study population
demographics, patient evaluations, and the frequency and severity of all
adverse events .
To evaluate safety and effectiveness of the Ascension MCP implant,
patients were stratified and evaluated based on two baseline medical
conditions: 1) osteoarthritis/post traumatic (OA/Trauma), and 2) rheumatoid
arthritis/systemic lupus erythematosus (RA/SLE) . Success/failure criteria with
respect to device effectiveness endpoints (including criteria for implanted joint
pain, joint function, and radiographic data) and success/failure criteria with
respect to device safety endpoints (including implant and bone fracture,
infection, and adverse biological reactions) were established retrospectively .
Separate success/failure criteria were defined for the OA/Trauma and RA/
SLE patient groups as summarized below . Each implant was determined to
have an outcome of excellent, good, unsatisfactory, or indeterminate . Implants
with an excellent or good outcome were considered a success while implants
with an unsatisfactory outcome were considered a failure . Patients lacking
information required as part of the success/failure definition were considered
indeterminate .
Patient Population and Demographics
The study population consisted of 45 females and 8 males with a mean age of
57 . 5 years (range 21 – 78 years) . Patients were diagnosed with one of four
conditions: 43 (81%) patients had rheumatoid arthritis (RA), 2 (4%) had
systemic lupus erythematosus (SLE), 5 (9%) had arthritis due to trauma (TA),
and 3 (6%) had osteoarthritis (OA) . For patients diagnosed with RA or SLE, the
mean time from diagnosis until implantation of the first Pyrocarbon MCP
implant was more than 16 years (range 3-36 years) .
Table 1. Patient Demographics and Baseline Clinical Characteristics.
Age (years)
N
Mean (sd)
Median
Min - Max
Gender
Male
Female
Hand dominance
Right
Left
Unknown
Diagnosis
OA
Trauma
RA
SLE
Time from diagnosis to first
pyrocarbon implant surgery
(years) for RA/SLE patients
N
Mean (sd)
Median
Min - Max
Patient Evaluations
The mean last evaluation time point for all patients was 8 . 6 years (range 1 . 7
months – 17 . 2 years) . Two years after receiving a Pyrocarbon MCP implant,
82% (41/50) of the patients were evaluated . At greater than ten years post
implantation, 72 . 5 % (29/40) of the patients were evaluated .
Table 2. Last Patient Evaluation Time Point.
Patients
N
Mean
Min - Max
Implants
N
Mean
Min - Max
Table 3. Proportion of Patients Evaluated Over Time.
Evaluation Cumulative
Patients
(years) Deaths
0 --
≤ 1 --
≤ 2 3
≤5 6
≤10 13
Complications and Adverse Events
The complications and adverse events identified during the case series
analysis of the Pyrocarbon MCP implant are provided below . The most
commonly reported patient adverse events were:
• recurrent deformity
• subluxation / dislocation
• re-operation for soft tissue reconstruction
• implant removal
• implanted joint pain, and
• synovitis .
3
All Diagnoses OA/Trauma
53 8
57 .5 (12 .6) 54 . 9 (18 .4)
60 60
21 - 78 21 - 77
8 (15%) 7 (88%)
45 (85%) 1 (12%)
49 (92%) 7 (88%)
2 (4%) 1 (12%)
2 (4%)
3 (6%) 3 (38%)
5 (9%) 5 (62%)
43 (81%) -
2 (4%) -
- -
- -
- -
- -
All Diagnoses OA/Trauma
53 8
8 .6 y 9 .0
1 . 7 m - 17 .2 y 1 . 7 m - 16 .0 y 8 . 1 m - 17 .2 y
147 9
7 .8 y 9 .4 y
0 . 9 m - 17 .2 y 1 . 7 m - 16 .0 y 0 . 9 m - 17 .2 y
Proportion of
Patients
Left Evaluated Patients Evaluated (%)
53 53
53 49
50 41
47 38
40 29
RA/SLE
45
58 .0 (11 .5)
58
35 - 78
1 (2%)
44 (98%)
42 (93%)
1 (2%)
2 (4%)
-
-
43 (96%)
2 (4%)
40
16 .3 (8 .4)
16 .0
2 (4%)
RA/SLE
45
8 .5
138
7 . 7 y
100%
92%
82%
81%
73%