Prospective, Randomized Controlled Study of Repairing the Anulus Fibrosus after Lumbar Discectomy: A...
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Transcript of Prospective, Randomized Controlled Study of Repairing the Anulus Fibrosus after Lumbar Discectomy: A...
127SProceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S
in Canada has not been assessed. The Canadian healthcare system provides
a unique opportunity to assess the impact of surgical volume on outcomes
as there is only a universally available healthcare system, in contrast to the
mixed private and public systems found in the USA, United Kingdom and
Australia.
PURPOSE: The purpose of the study was to assess the relationship
between the likelihood of adverse events related to surgery and the volume
of surgery for adolescent idiopathic scoliosis in Canada.
STUDY DESIGN/SETTING: A retrospective cohort study utilizing CI-
HI-DAD, a national validated administrative discharge database in Canada.
PATIENT SAMPLE: All 1225 patients in the CIHI-DAD with the
diagnosis of adolescent idiopathic scoliosis, aged 11–17, who underwent
a spinal fusion between 2003–2007 were included.
OUTCOME MEASURES: Inpatient mortality rate, length of stay and
adverse event rates as defined as wound infection, hematomas, neurologic
injury, hardware failure, homologous red blood cell transfusions.
METHODS: Demographic data and outcome measures were obtained
from the CIHI-DAD, with both univariate and logistic regression analysis
were performed to analyze the effect of hospital volume on outcome
measures.
RESULTS: There were no in hospital deaths among the 1225 AIS patients
who had fusion surgery. 57% were admitted to a post-operative intensive
care unit or step down unit with an average length of stay of 1.7 +/- 3.6
days. Average total length of stay in hospital was 7.9 +/- 7.4 days, with
over 98% of patients going home. Wound infection (1.47%) and wound
-hematomas(1.88%) and hardware failure (1.39%) were the most common
local complications. Neurologic injury was rare (0.49%). Systemic compli-
cations such as DVT, pneumonia and cardiac arrhythmias were also rare
(0.08%, 0.33% and 0.16%). 32.57% of patients received red blood cell
transfusion. Wound infection rates varied inversely with increasing quan-
tiles of surgical volume (OR 0.54 [0.36, 0.819]). Not receiving red cell
transfusion varied inversely with increasing quantiles of surgical volume
(OR 1.21 [1.11, 1.31]). Overall, the odds of having any adverse event
following surgery, was significantly higher in surgical centers having the
lowest quantiles of surgical volume compared to centers with the highest
quantile (OR 2.62 [1.27,5.4]).
CONCLUSIONS: Overall, rates of both local and systemic adverse events
are low. However, wound infection rates and red blood cell transfusions
and overall adverse events decrease with increasing quantiles of surgical
volume in adolescent idiopathic scoliosis. In a publicly funded health
system, with universal coverage, centralization of centers performing
AIS surgery has the potential to reduce adverse events such as wound
infections and red cell transfusion.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2010.07.330
P55. Prospective, Randomized Controlled Study of Repairing the
Anulus Fibrosus after Lumbar Discectomy: A Single Surgeon’s
Experience
Alexander Bailey, MD1, Julie Messer2, Steven L. Griffith, PhD2;1Heartland Spine and Specialty Hospital, Overland Park, KS, USA;2Anulex Technologies, Minnetonka, MN, USA
BACKGROUND CONTEXT: Lumbar micro-discectomy is considered to
be a relatively safe and successful surgery. The current practice of leaving
an open defect in the anulus fibrosus at the conclusion of a lumbar discec-
tomy may lead to an increased potential for re-herniation which may result
in additional surgery. Repair of the defect in the anulus appears to be a rea-
sonable and logical approach to mitigate this outcome and possibly reduce
the incidence of reoperation for recurrent herniated nucleus pulposus.
PURPOSE: This study investigates the perceived benefits of repairing the
anulus fibrosus.
All referenced figures and tables will be available at the Annual Mee
STUDY DESIGN/SETTING: Prospective, randomized, controlled study
from a single surgeon.
PATIENT SAMPLE: Sixty-six patients were screened for enrollment into
this prospective study.
OUTCOMEMEASURES: The Oswestry Disability Index, the SF-12 and
visual analog scales (VAS) for both low back and leg pain were collected.
All complications, including the need for additional surgery, are also
noted.
METHODS: Patient informed consent allowed for intra-operative ran-
domization at the conclusion of standard discectomy techniques in 2:1
manner, anular repair with Xclose Tissue Repair System (Anulex Technol-
ogies Inc, Minnetonka MN) vs. no repair, respectively. In this ongoing
study, patient outcomes are determined pre-operatively as well as 2 weeks
(n563), 6 months (n547), 12 months (n534) and 18 months (n57). Over-
all average time from surgery was 14.6 months (range: 2.3 to 23.8 months).
RESULTS: Of the 66 patients screened for enrollment, 3 were excluded
intra-operatively (due to concerns of poor tissue quality); in three others,
anular repair was unsuccessfully attempted. Randomization resulted in
44 patients receiving anular repair (AR group) and 16 patients receiving
no anular repair (NAR group). Patient outcomes showed a similar improve-
ment in both groups immediately after surgery that was maintained
throughout the follow-up periods. There were a total of seven cases that
required additional surgery (11.1%). One of the three attempted (but un-
successful) repair required a second surgery, and the NAR group had
two reoperations (12.5%). In the attempt to treat group and the NAR
group, all reoperations were for recurrent herniated nucleus pulposus;
same level, same side, and same location (true recurrent herniation). Four
patients in the AR group required additional surgery (9.1%). The AR group
had two reoperations for recurrent herniated nucleus pulposus (4.5%). One
additional patient developed a far lateral herniation remote from previous
herniated disc and repair and the other patient required fusion for post-
laminectomy syndrome/degenerative disc disease. The reduction in inci-
dence of surgery for true recurrent herniations was 64.0%. Using the most
conservative methods, the reduction in additional surgery, regardless of
reason, was 27.2%.
CONCLUSIONS: Anular repair using Xclose Tissue Repair System can
be successfully accomplished in greater than 90% of cases if the discec-
tomy is performed with the ultimate goal of repair being appreciated.
Repairing the anulus fibrosus was shown to be beneficial by reducing
the need for additional surgery, in particular those re-operations for true
recurrent herniation.
FDA DEVICE/DRUG STATUS: Xclose Tissue Repair System: Approved
for this indication.
doi: 10.1016/j.spinee.2010.07.331
P56. Rating the Whole Person Impairment Due to the Spine and the
Pain Disability Status of Individuals with Polytrauma History over
2 Years, According to the AMA Guides to the Evaluation of
Permanent Impairment, Sixth Edition
Armando S. Miciano, MD; Nevada Rehabilitation Institute, Las Vegas, NV,
USA
BACKGROUND CONTEXT: There has been no systematic research on
the reliability of the Whole Person Impairment Rating due to the Spine
(WPIS) or the pain-related impairment (PRI) system developed for the
Sixth edition of the AMA Guides to the Evaluation of Permanent Impair-
ment, or of any other system for evaluating WPIS or PRI.
PURPOSE: The objective is to examine the pain-related impairment (PRI)
of polytrauma patients with chronic pain (CP) and with a spine impairment
using the Pain Disability Questionnaire (PDQ), a formal assessment of
pain disability by the AMA Guides to Evaluation of Permanent Impair-
ment, Sixth Edition.
STUDY DESIGN/SETTING: A cross-sectional case series study was un-
dertaken in a referral-based outpatient rehabilitation clinic.
ting and will be included with the post-meeting online content.