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Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

Lequin MB, Barth M, Thomė C, Bouma GJ - Korean J Spine (2012)

Bottom Line: Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence.One reherniation has occurred (2.4%), which was associated with a misplaced device.Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, Sint Lucas-Andreas Ziekenhuis and Academic Medical Center, Amsterdam, The Netherlands.

ABSTRACT

Objective: Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor.

Methods: We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up.

Results: At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed.

Conclusion: The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

No MeSH data available.


Related in: MedlinePlus

Mean disc height maintenance. Error bars represent standard deviation.
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Figure 8: Mean disc height maintenance. Error bars represent standard deviation.

Mentions: As depicted in the patient flowchart in Fig. 4, radiographic data necessary to evaluate disc height were available for 30 of these 40 patients. There was a small but significant decrease of the mean disc height to 92.8% of baseline (S.D. 7.9%) (Fig. 8) at 12 months (p<0.01, one-sided Student t-test). No statistically significant differences were found between mean preoperative and 12-month evaluations for disc angle, spondylolisthesis, rotation and translation. Furthermore, no evidence was found of heterotopic ossification or spontaneous fusion. In all cases, the device was intact, with no signs of subsidence or migration. The degree of facet joint arthopathy and disc degeneration preoperative and at 12 months are presented in Tables 3 and 4. The differences noted were not statistically significant (Fisher's Exact: p=0.781 for facet joint arthropathy and p=0.857 for disc degeneration)


Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

Lequin MB, Barth M, Thomė C, Bouma GJ - Korean J Spine (2012)

Mean disc height maintenance. Error bars represent standard deviation.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4430560&req=5

Figure 8: Mean disc height maintenance. Error bars represent standard deviation.
Mentions: As depicted in the patient flowchart in Fig. 4, radiographic data necessary to evaluate disc height were available for 30 of these 40 patients. There was a small but significant decrease of the mean disc height to 92.8% of baseline (S.D. 7.9%) (Fig. 8) at 12 months (p<0.01, one-sided Student t-test). No statistically significant differences were found between mean preoperative and 12-month evaluations for disc angle, spondylolisthesis, rotation and translation. Furthermore, no evidence was found of heterotopic ossification or spontaneous fusion. In all cases, the device was intact, with no signs of subsidence or migration. The degree of facet joint arthopathy and disc degeneration preoperative and at 12 months are presented in Tables 3 and 4. The differences noted were not statistically significant (Fisher's Exact: p=0.781 for facet joint arthropathy and p=0.857 for disc degeneration)

Bottom Line: Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence.One reherniation has occurred (2.4%), which was associated with a misplaced device.Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, Sint Lucas-Andreas Ziekenhuis and Academic Medical Center, Amsterdam, The Netherlands.

ABSTRACT

Objective: Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor.

Methods: We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up.

Results: At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed.

Conclusion: The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

No MeSH data available.


Related in: MedlinePlus