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Orthopaedic Surgery Spine
Peri-radicular Lumbar Fibrosis – What to Do?
a report by
Iñaki Arrotegui and Jose Luis Llombart
Department of Neurosurgery, Hospital General de Valencia
Purpose of Study adhesion barrier. It is likely that the collagen dural matrix may be used
The objective of this retrospective clinical study was to investigate the in other regions of the spine to prevent peridural fibrosis and associated
potential benefits of using the collagen dural matrix as an adhesion barrier sequelae. Ultimately, the prophylactic use of the collagen dural matrix
following spine surgery in order to avoid peri-radicular lumbar fibrosis. to prevent adhesions may result in improved patient outcomes.
Methods Used Objective
The retrospective patient data of 430 patients were used. The study cohort The primary objective of this study was to evaluate re-operation rates in
(collagen dural matrix group) consisted of 250 consecutive patients who spinal surgery patients treated with Dural Graft Matrix
®
compared with
were treated with DuraGen
®
. Patients in the standard procedure group similar patients given standard treatment. The secondary objectives
(180 patients) were operated on prior to the adoption of DuraGen use by included the comparison of the two groups of patients with regard to
the surgeon. Patients underwent spinal surgery and completed follow-up post-surgical pain and the occurrence of adhesions.
evaluations at no less than three years post-operation.
Study Design and Procedure
Study Design This study was based on a retrospective review of medical records from
Following surgery, pain was assessed at various times post-operation (0 to six Hospital General Universitario de Valencia, Spain. The study population
months, six to 12 months and 12 to 48 months). A post-operative magnetic consisted of patients who underwent spinal surgery and who had
resonance imaging (MRI) scan was performed on patients experiencing documented follow-up visits for at least three months afterwards. From
excessive pain to assess the extent of peridural scarring and adhesions.
Summary of Findings
The need exists for treatments to
Post-operative Pain Assessment
Mean post-operative pain scores for the collagen matrix group at all time
prevent dural adhesions and minimise
points were lower than those for the standard procedure group, and
the impact of peridural fibrosis on the
were statistically lower at three to six months.
post-operative outcome of spine surgery.
Comparison of Post-operative and Pre-operative
Magnetic Resonance Imaging
Of the patients who received post-operative MRI, 43% of those in the
standard procedure group showed adhesion formation, while 23% of mid-2000 until the current time, all of the spinal surgery patients received
those in the collagen matrix group showed adhesions. the Dural Graft Matrix as an adhesion barrier. Prior to this time, all
patients received standard treatment. Records were available for
Re-operation Rate 250 DuraGen patients and 180 standard procedure patients. AII of the
The difference in the re-operation rates between the collagen matrix group DuraGen and the standard procedure patients were found to be eligible
and the standard procedure group is statistically significant (p<0.01). for evaluation based on the criteria specified on the case report form.
Relationship Between Findings and Existing Knowledge Data Summary Method and Statistical Consideration
Dural adhesions resulting from peridural fibrosis can cause persistent pain The two treatment groups were summarised in terms of demographics
and may lead to re-operation. The need exists for treatments to prevent dural re-operation, pain severity and occurrence of adhesions. For any parameter,
adhesions and minimise the impact of peridural fibrosis on the post-operative if the subgroups were too small the data were summarised by treatment
outcome of spine surgery. Collagen dural matrix has traditionally been used groups without formal statistical comparison. If patient counts were large
for the repair of dural defects in both cranial and spinal procedures. Due to enough, continuous variables were compared between the treatment
DuraGen’s excellent clinical profile, it may be useful as an adhesion barrier. groups by a two-sample t-test, and categorical variables were evaluated by
either a chi-squared or Fisher’s Exact test. Statistical significance was defined
Overall Significance of Findings for all tests as p<0.05 (two-sided). Although many comparisons were
Findings in this study (reduced pain and lower incidence of adhesions) performed, no adjustment for multiple comparisons was made. In addition,
are consistent with the collagen dural matrix acting as an effective re-operation rates were evaluated using the Kaplan-Meier analysis.
© TOUCH BRIEFINGS 2008 55
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