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Table 4. Complications and Adverse Events.
Complication /
Adverse Event
Recurrent Deformity
Subluxation/Dislocation
Soft-tissue Re-operation
Implant Removal
Implanted joint pain
Synovitis
Stiffness / Loss of Motion
Subsidence
Loosening
Black Tissue Stain
Implant modification
Radiographic changes:
lucency
sclerosis
heterotopic bone
cyst
erosion
Superficial Wound Infection
Sensory Abnormality
Excessive erythema
Implant Fracture;
in vivo fracture
intra-op fracture:
at implantation
at removal
Bone Fracture:
in vivo fracture
intra-op fracture
Implant Removals
A total of 21 (14%) Pyrocarbon MCP implants were removed from 11 (21%)
patients . No implants were removed for implant fracture or clinical
complications such as bone fracture, infection, sensory abnormality, allergic or
foreign body reaction, iatrogenic complications or wound complications .
Three (2%) implants were removed for loosening while 18 implants (12%) were
removed for deformity associated with disease progression related to RA/SLE
(extensor lag, flexion contracture, ulnar deviation, subluxation or dislocation) .
All removed implants were successfully revised; fifteen were replaced with
silicone spacers, four Pyrocarbon MCP implants were reinserted with bone
cement, and two new Pyrocarbon MCP implants were used . Of the 21
implants that were removed, 6 implants were removed less than 1 year after
implantation; 9 implants were removed between 1 and 5 years after
implantation; and 6 implants were removed greater than 5 years after
implantation (range 5-11 years) .
Table 5. Summary of Implant Removals.
All Diagnoses
(N=53 patients)
Number of Implants
Number of Removals
Reason for Removal
Fracture
Loosening, Subsidence,
Migration
Clinical Complication
Disease Progression
Soft Tissue Re-Operations
Eleven (11) soft tissue re-operation procedures were performed on a 22 (15%)
joints in 11 (21%) Pyrocarbon MCP patients . Procedures were performed to
correct recurrent MCP joint deformities such as implant subluxation/
dislocation, ulnar/radial deviation, extension lag or loss of motion, or
extension contracture . All but one of the soft tissue re-operations was on RA/
SLE patients . Three (3) of the 22 implants were eventually removed, all due to
recurrent subluxation or dislocation . Sixteen (16) of the 22 joints were
operated on less than 1 year post-implantation .
Implants
%
Patients
Implants
(N = 53)
(N = 147)
49
33%
20
31
21%
17
22
15%
11
21
14%
11
13
9%
11
24
16%
10
12
8%
6
9
6%
6
7
5%
5
7
5%
4
5
3%
3
4
3%
3
1
1%
1
2
1%
2
1
1%
1
2
1%
1
--
--
2
3
2%
2
2
1%
2
0
0%
0
4
3%
4
6
4%
3
0
0%
0
3
2%
2
OA/Trauma
RA/SLE
(N=8 patients)
(N=45 patients)
147
9
21 (14%)
1 (11%)
20 (14%)
0 (0%)
0 (0%)
0 (0%)
3 (2%)
1 (11%)
2 (1%)
0 (0%)
0 (0%)
0 (0%)
18 (12%)
0 (0%)
18 (13%)
Table 6. Summary of Soft Tissue Re-operations.
%
Patients
38%
Number of Implants
32%
21%
Number of Implants Re-operated
21%
Reason for Re-operation
21%
Subluxation / Dislocation
19%
Ulnar / Radial Deviation
11%
Extension Lag / Loss of Motion
11%
Extension Contracture
9%
8%
Intraoperative Implant Fractures
6%
There were a total of 10 intraoperative Pyrocarbon MCP implant fractures, i . e . ,
fractures that occurred during either implantation or revision of the device .
6%
Four of the 10 intraoperative fractures occurred during the implantation of 295
2%
components for a rate of 1 . 4 % (4/295) . In 3 of the 4 cases, the fractured
4%
component was easily removed and a new Pyrocarbon MCP component was
2%
inserted while in the fourth case, the fragment was left in situ and a silicone
2%
spacer was inserted . Six of the 10 fractures occurred during implant revision
and removal of 42 components (21 devices) for a rate of 14% (6/42) . Five of
4%
these fractured devices were replaced with a silicone spacer while the 6th
4%
fractured device was essentially intact and was reinserted with bone cement .
4%
All intraoperative fractures were uneventful and no sequelae resulted .
0%
Black Staining of Tissue and Synovitis
Although the sponsor concluded that there was no adverse tissue reaction to
8%
the Pyrocarbon MCP joint implant, carbon particles, or "fine particle matter"
6%
in samples evalu ated by the histopathologist, there were reports of black
staining of tissue and synovitis .
0%
4%
Black Staining of Tissue
A total of 7 implants caused black stained tissue in 4 of 53 patients for a rate of
7 . 5 % (4/53) . Four (4) events occurred during removal of implants from each
finger on one patientʼs hand . All four fractured implants were removed by
drilling them out of the bone . After the drilling process, black stained tissue
was observed in each finger . No tissue samples were taken from this patient .
In addition, there were 3 events observed during operations to remove
implants that were potentially loose in 3 patients . Tissue samples from these
three patients were excised during removal for histopathologic examination .
The histopathologist concluded that the tissue did not reveal any negative
tissue reaction . All implants were revised . Two (2) implants were revised to
silicone spacers and 1 Pyrocarbon MCP implant was reinserted with cement .
Synovitis
A total of 24 synovitis events were reported for 10 patients for a rate of 19%
(10/53) . Tissue samples were available for examination from 5/24 joints
including samples from 2 RA patients and one Trauma patient . The
histopathologistʼs review concluded that there was no adverse tissue reaction
to the implant, carbon particles, or "fine particle matter" in these samples .
Success/Failure Analyses
To evaluate safety and effectiveness of the Ascension MCP implant, patients
138
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 criteria were
considered indeterminate .
The OA/Trauma patients and the RA/SLE patients presented with distinct
treatment objectives and associated physician expectations . Treatment
objectives and physician expectations were derived retrospectively from the
pre-operative notes and physical exam records . Safety and effectiveness
criteria were defined retrospectively with the treatment objectives and
physician expectations in mind .
4
All Diagnoses
OA/Trauma
(N=53 patients)
(N=8 patients)
(N=45 patients)
147
9
22 (15%)
1 (11%)
7 (5%)
0 (0%)
7 (5%)
1 (11%)
5 (3%)
0 (0%)
3 (2%)
0 (0%)
RA/SLE
138
21 (15%)
7 (5%)
6 (4%)
5 (4%)
3 (2%)
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