Integra Ascension MCP Manual Del Usario página 7

Safety Results (RA/SLE)
Intraoperative implant fractures occurred in two patients during implantation
of the device . In one patient the fractured component was removed and a new
Pyrocarbon MCP component was inserted successfully while in the other
patient the fractured fragment was left in situ and a silicone spacer was
successfully inserted . In addition, 6 components fractured in 3 patients during
revision . As noted above, all implants that fractured during removal were
successfully revised; silicone spacers were inserted in 2 patients, and the
fractured Pyrocarbon MCP implant removed from the third patient was
reinserted with bone cement . Similar to the OA/Trauma cohort, there were no
other reported occurrences of the implant safety criteria listed above . A
complete list of adverse events for the entire study population was provided in
Table 4 .
OA/Trauma Patients
Treatment objectives (OA/Trauma)
The OA/Traumatic Arthritis patients presented with damaged or destroyed
articular surfaces and almost always had pain and limited motion . Most of
these patients needed treatment in only one MCP joint; only one patient
required treatment in multiple MCP joints .
For the OA/TRAUMA cases, the physician had the expectation that total
joint arthroplasty would relieve pain, maintain reasonable joint range of
motion (ROM), and maintain joint reduction .
Success/Failure Analysis (OA/Trauma)
For the OA/TRAUMA group, effectiveness criteria were defined for a greater
than 2 year treatment outcome analysis . Two (2) years was set as the minimum
amount of time that the surgical improvement must be maintained to be
deemed successful .
Effectiveness Analysis (OA/Trauma)
For the OA/Trauma 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 and radiographic data > 2 years indicating:
a . Pain free implant at last follow-up;
b . Increase in range of motion (ROM) from baseline, or ROM > 50
degrees 3 ; and
c . Reduced implant position .
Good
1 . Physical exam, ROM and radiographic data < 2 years indicating:
a . Increase in ROM from baseline, or ROM > 50 degrees; and
b . Reduced implant position; and
2 . Physical exam or telephone conversation with a physician > 2 years
indicating:
a . pain free implant; and
b . implant survival
Unsatisfactory
1 . Implant related pain at last evaluation;
2 . Implant loosening or removal;
3 . Post-operative implant fracture;
4 . Decrease in ROM fro m baseline with ROM < 50 degrees; or
5 . Implant subluxation or dislocation .
Indeterminate
1 . No information > 2 years or insufficient information > 2 years to indicate
maintenance of the improvements .
Effectiveness Results (OA/Trauma)
In the OA/Trauma cohort, the effectiveness analysis revealed the following:
Table 10. OA/Trauma Effectiveness Results.
"Success"
"Failure"
"Indeterminate"
Patients w/ All Implants "Success"
Patients w/ All Implants "Failure"
Patients w/ All Implants "Indeterminate"
Seven of the nine (78%) implants in this cohort were determined to be a
"Success" while only 1 implant (11%) was a "Failure" . Six implants had an
excellent outcome, 1 implant had a good outcome, 1 implant was
unsatisfactory, and 1 implant was indeterminate .
The implant with an unsatisfactory result was removed due to loosening
at 1 . 1 years and revised with a new Pyrocarbon MCP implant with cement . No
other implants in this cohort loosened or were removed .
The 6 implants that had an excellent outcome had their last evaluation
ranging from 3 . 5 to 16 . 0 years, and all but 1 implant demonstrated an increase
in ROM . For the 1 implant that did not show increased ROM, the post-
operative ROM was very good at 65 degrees .
The implant with a good outcome had a last evaluation indicating implant
survival at 17 years, while the implant with indeterminate outcome had a 0 . 5 -
year evaluation demonstrating good improvement . All implants demon strated
no joint pain at final evaluation except for the unsatisfactory implant that had
pain secondary to loosening .
Safety Analysis (OA/Trauma)
The frequency and severity of the following events were evaluated for
purposes of determining device safety in the OA/Trauma group:
1 . Intraoperative implant fracture
2 . Non-intraoperative implant fracture
3 . Unstable intraoperative bone fracture
4 . Post operative bone fractures
5 . Implant related infection
6 . Adverse biological reaction to implant
Safety Results (OA/Trauma)
There were 2 intraoperative implant fractures that occurred in 2 patients in this
cohort . Both fractures occurred during implantation, and both fractured
implants were removed and a new Pyrocarbon MCP implant was inserted
without sequelae . There were no other reported occurrences of the implant
safety criteria listed above . A complete summary of adverse events for the
entire study population was provided in Table 4 .
Surgical Procedure
A Surgical Technique manual is available which outlines the basic procedure
for device implantation and removal and the use of specialized surgical
instrumen tation, which will provide optimum implantation and
reconstruction results .
Meticulous preparation of the implant site and selection of the proper size
implant increase the potential for successful reconstruction . A complete set of
instruments for each type of implant is available to aid bone preparation and
reduce the operative time . It is suggested that the proper size implant be
removed from its sterile package only after the implant site has been prepared
and properly sized .
Anatomical dimensions limit the physical size of the device that can be
implanted . In most cases, the largest possible implant should be selected
which, in the opinion of the surgeon, does not require excessive bone
resection or in any way limits function or healing .
Post-operative Therapy
Post-operative therapy for the Ascension MCP implant differs for rheumatoid
arthritis and osteoarthritis/post-traumatic arthritis patients . A Post-Operative
Therapy Protocol is available which summarizes post-operative care . For
further information, please contact Ascension Orthopedicsʼ Customer Service
toll-free at 877-370-5001 .
Training
Surgeons should obtain training from a qualified instructor prior to implanting
the Ascension MCP implant to ensure thorough understanding of the
indications, implantation and removal techniques, instrumentation, and post-
operative rehabilitation protocol . Please contact Ascension Orthopedicsʼ
7
Implants Patients
(N = 9) (N = 8)
7 (78%)
(6 Excellent, --
1 Good)
1 (11%) --
1 (11%) --
-- 6 (75%)
-- 1 (12 .5%)
-- 1 (12 .5%)