Integra Ascension MCP Manual Del Usario página 5

RA/SLE Patients
Treatment Objectives (RA/SLE)
The following 4 potential primary objectives for finger joint replacement in the
RA/SLE group were defined:
A . In cases with limited extension (that is 30 degrees or more of extension
lag), the primary expectation was to increase extension .
B . In cases with pain, the primary expectation was to relieve pain .
C . In cases with a destroyed or eroded articular surface, the primary
expectation was to replace the eroded surfaces and provide a reduced
joint .
D . In cases with a pre-operative dislocation, the primary expectation was
to provide a reduced or subluxed joint .
E . And, in cases presenting with a combination of these conditions, that
is A, B, C, and/or D, the primary objective was to address each of the
individual conditions .
Each patientʼs treatment objectives were derived retrospectively from pre-
operative surgeonʼs notes and physical exam records .
Success/Failure Analysis (RA/SLE)
For the RA/SLE group, effectiveness criteria were defined for a 1-5 year
treatment outcome analysis, and for a longer-term treatment outcome
analysis . Both sets of criteria acknow ledge and accommodate the potential
confounding influence on treatment outcomes of soft tissue attenuation
related to progression of the RA/SLE baseline medical condition .
Effectiveness Analysis (RA/SLE 1-5 Year Evaluation)
For the RA/SLE cohort, the following effectiveness criteria were applied on an
implant basis to determine the treatment outcome category for each implant .
An implant with an Excellent or Good outcome was considered a Success
while an implant with an Unsatisfactory outcome was considered a Failure .
Excellent
1 . Physical exam, ROM data, and radiographic data > 1 year 1 indicating:
a . Improvement of all treatment objectives;
b . Pain free joint; and
c . Reduced implant position .
2 . Subjective or objective information indicating a reduction in the
improvement of treatment objectives after 5 years is acceptable .
Good
1 . Physical exam, ROM data, and radiographic data
< 1 year 1 indicating:
a . Improvement of all treatment objectives;
b . Pain free joint; and
c . Reduced implant position; and
2 . Subjective or objective information (a physical exam at another clinic
(ortho pedic, rheumatolgy, etc . ) , radiographic data, a questionnaire or
telephone conversation with a physician) at > 1 year indicating:
a . maintenance of the improvements; or
b . implant survival .
3 . Subjective or objective information indicating a reduction in the
improvement of treatment objectives after 5 years is acceptable
Unsatisfactory
1 . Primary treatment objective(s) same or not improved by the surgery;
2 . Implant related pain at last evaluation;
3 . Implant loosening;
4 . Implant removal < 5 years;
5 . Implant dislocation < 5 years; or
6 . Post-operative implant fracture
Indeterminate
1 . No information > 1 year, or insufficient information
> 1 year to indicate maintenance of the improvements at < 5 years
Effectiveness Results (RA/SLE 1-5 Year Evaluation)
In the RA/SLE cohort, the 1-5 year effectiveness analysis revealed the following:
Table 7. RA/SLE 1-5 Year Effectiveness Results.
"Success"
"Failure"
"Indeterminate"
Patients w/ All Implants "Success"
Patients w/ All Implants "Failure"
Patients w/ All Implants "Indeterminate"
Patients w/ multiple Implant Outcomes
("Success" and/or "Failure",
and/or "Indeterminate"
Forty-six (46) implant outcomes were considered excellent with a final
evaluation occurring at an average of 8 . 3 years (range 1 . 0 -16 . 8 years) after
implantation, and 37 of the 46 implants having a final evaluation > 2 years after
implan tation . Thirty-six (36) implant outcomes were considered good with a
final evaluation occurring at an average of 5 . 9 years (range 1 . 2 -13 . 6 years) after
implantation, and 22 of the 36 implants having a final evaluation > 2 years after
implantation . Thus, 59 of the 82 successful implants had a final evaluation at
greater than 2 years after implantation, a rate of 72% (59/82) .
Successful implants were in 33 of the 45 RA/SLE patients, a rate of 73%
(33/45) . Of the 33 patients who had at least one successful implant, 27 had all
their implants considered successful, a rate of 82% (27/33) . Therefore, 60%
(27/45) of the patients in the RA/SLE cohort had all their implants considered
successful .
For the group of implants demonstrating excellent and good outcomes,
there were no reports of implanted joint pain at a final evaluation occurring at
an average of 6 . 4 years (range 0 . 4 to 16 . 8 years) after implantation, with 1
patient reporting hand pain at 10 . 0 years . The average extension increase was
34 . 0 degrees (range –20 to 125 degrees) with a final evaluation occurring at an
average of 2 . 0 years (range 0 . 1 to 11 . 7 years) after implantation . All patients with
a primary treatment expectation of increasing extension showed an extension
increase except for 2 implants (1 each in 2 patients) that showed no increase,
but had ROM > 40 degrees . Accordingly, these 2 implants had an outcome of
Good . Five implants in 4 patients with a treatment expectation of joint
reduction and/or surface replacement and/or pain relief showed an extension
decrease, but had good to excellent post-operative ROM averaging 29 . 0
degrees (range 20 to 50 degrees) . Of the 82 implants considered successful, 77
had a final radiographic evaluation that showed 61 implants reduced at an
average of 3 . 9 years (range 0 . 1 to 12 . 9 years) after implantation, a rate of 79%
(61/77) . Eleven implants were subluxed (average final evaluation of 7 . 0 years,
range 1 . 4 - 13 . 0 years), and 5 were dislocated . Of the 5 dislocated implants, 4
were in one patient with 2 dislocations noted at 10 . 0 years and 2 more noted
at 11 . 5 years, and the 5th was in another patient and noted at 11 . 0 years after
implantation . There were 6 implants removed from 2 patients in this group; 4
implants were removed from 1 patient at 5 . 5 years due to disease related
flexion contracture and ulnar deviation deformity, and 2 implants were
removed from the other patient at 11 . 0 years due to subluxation/dislocation
related to soft tissue attenuation . All removed implants were successfully
converted to a silicone spacer .
For the group of implants with an unsatisfactory outcome, 14 implants in 8
patients were removed . Two implants were removed due to loosening (1 at 1 . 5
years and 1 at 4 . 9 years) . The 12 other implants removed were revised due to
disease related soft tissue degradation that resulted in flexion contracture (4
implants: 2 each in 2 patients), ulnar deviation deformity and dislocation
(3 implants in 1 patient), or subluxation/dislocation (5 implants: 1 in 1 patient,
and 2 each in 2 other patients) . All removed implants were successfully revised
(9 were replaced with silicone spacers, 4 Pyrocarbon MCP implants were
reinserted with bone cement, and 1 new Pyrocarbon MCP implant was
inserted) .
The other 23 implants with an unsatisfactory outcome were in 8 patients,
and were unsuccessful due to extension contractures (4 implants: 3 in 1 patient
and 1 in another patient), lack of extension improvement or extension deficit
(12 implants: 4 each in 2 patients, and 2 each in 2 other patients), recurrent
severe ulnar deformity (4 in 1 patient) and dislocation (3 implants: 2 in 1 patient
and 1 in another patient) . Thus, of the 37 implants with unsatisfactory
outcome in 15 patients, only 2 were directly related to implant loosening . All
other unsatisfactory outcomes were due to disease related soft tissue
degradation leading to loss of extension or joint location, or recurrent ulnar
deformity .
5
Implants Patients
(N = 138) (N = 45)
82 (59%)
(46 Excellent, --
36 Good)
37 (27%) --
19 (14%) --
-- 27 (60%)
-- 8 (18%)
-- 3 (7%)
-- 7 (15%)