Dynamic stabilization devices in the treatment of low back pain

Sengupta, Dilip K.

doi:10.1016/s0030-5898(03)00087-7

Cited by 144 publications

(74 citation statements)

References 57 publications

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“…To avoid adjacent disc hyper-mobility and the possible resulting progression of degeneration, dynamic implants have been developed [10,18,32,33]. Therapeutic strategy of these implants is stabilization by reducing loads while allowing motion in the treated segment.…”

Section: Introductionmentioning

confidence: 99%

Dynamic stabilization adjacent to single-level fusion: Part I. Biomechanical effects on lumbar spinal motion

et al. 2010

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Progression of superior adjacent segment degeneration (PASD) could possibly be avoided by dynamic stabilization of an initially degenerated adjacent segment (AS). The current study evaluates ex vivo the biomechanics of a circumferential fixation connected to posterior dynamic stabilization at the AS. 6 human cadaver spines (L2-S1) were stabilized stepwise through the following conditions for comparison: intact spine (ISP), single-level fixation L5-S1 (SLF), SLF ? dynamic AS fixation L4-L5 (DFT), and two-level fixation L4-S1 (TLF). For each condition, the moments required to reach the range of motion (ROM) of the intact whole spine segment under ±10 Nm (WSP10) were compared for all major planes of motion within L2-S1. The ROM at segments L2/3, L3/4, and L4/5 when WSP10 was applied were also compared for each condition. The moments needed to maintain WSP10 increased with each stage of stabilization, from ISP to SLF to DFT to TLF (p \ 0.001), in all planes of motion within L2-S1. The ROM increased in the same order at L3/4 (extension, flexion, and lateral bending) and L2/3 (all except right axial rotation, left lateral bending) during WSP10 application with 300 N axial preload (p \ 0.005 in ANOVA). At L4/5, while applying WSP10, all planes of motion were affected by stepwise stabilization (p \ 0.001): ROM increased from ISP to SLF and decreased from SLF to DFT to TLF (partially p \ 0.05). The moments required to reach WSP10 increase dependent on the number of fixated levels and the fixation stiffness of the implants used. Additional fixation shifts motion to the superior segment, according to fixation stiffness. Therefore, dynamic instrumentation cannot be recommended if prevention of hyper-mobility in the adjacent levels is the main target.

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Section: Introductionmentioning

confidence: 99%

Dynamic stabilization adjacent to single-level fusion: Part I. Biomechanical effects on lumbar spinal motion

et al. 2010

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“…Recently, interspinous spacers have been introduced for surgery of degenerative lumbar disc diseases as a concept of dynamic stabilization [4,22,23]. The device for intervertebral assisted motion (DIAM TM ) is a relatively new interspinous spacer consisting of silicone core, polyester mesh, fixation cables, and titanium crimps [26].…”

Section: Introductionmentioning

confidence: 99%

Survivorship analysis of 150 consecutive patients with DIAM™ implantation for surgery of lumbar spinal stenosis and disc herniation

2010

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Recently, the Device for Intervertebral Assisted Motion (DIAM TM ) has been introduced for surgery of degenerative lumbar disc diseases. The authors performed the current study to determine the survivorship of DIAM TM implantation for degenerative lumbar disc diseases and risk factors for reoperation. One hundred and fifty consecutive patients underwent laminectomy or discectomy with DIAM TM implantation for primary lumbar spinal stenosis or disc herniation. The characteristics of the 150 patients included the following: 84 males and 66 females; mean age at the time of surgery, 46.5 years; median value of followup, 23 months (range 1-48 months); 96 spinal stenosis and 54 disc herniations; and 146 one-level (115, L4-5; 31, L5-6) and 4 two-level (L4-5 and L5-6). In the current study, due to lumbosacral transitional vertebra (LSTV) L6 meant lumbarization of S1 and this had a prominent spinous process so that the DIAM TM was implanted at L5-6. Reoperations due to any reasons of the DIAM TM implantation level or adjacent levels were defined as a failure and used as the end point for determining survivorship. The cumulative reoperation rate and survival time were determined via Kaplan-Meier analysis. The log-rank test and Cox regression model were used to evaluate the effect of age, gender, diagnosis, location, and level of DIAM TM implantation on the reoperation rate. During a 4-year follow-up, seven patients (two males and five female) underwent reoperation at the DIAM TM implantation level, giving a reoperation rate of 4.7%. However, no patients underwent reoperation for adjacent level complications. The causes of reoperation were recurrent spinal stenosis (n = 3), recurrent disc herniation (n = 2), post-laminectomy spondylolisthesis (n = 1), and delayed deep wound infection (n = 1). The mean time between primary operation and reoperation was 13.4 months (range 2-29 months). Kaplan-Meier analysis predicted an 8% cumulative reoperation rate 4 years post-operatively. Survival time was predicted to be 45.6 ± 0.9 months (mean ± standard deviation). Based on the log-rank test, the reoperation rate was higher at L5-6 (p = 0.002) and two-level (p = 0.01) DIAM TM implantation compared with L4-5 and one-level DIAM TM implantation. However, gender (p = 0.16), age (p = 0.41), and diagnosis (p = 0.67) did not significantly affect the reoperation rate of DIAM TM implantation. Based on a Cox regression model, L5-6 [hazard ratio (HR), 10.3; 95% CI, 1.7-63.0; p = 0.01] and two-level (HR, 10.4; 95% CI, 1.2-90.2; p = 0.04) DIAM TM implantation were also significant variables associated with a higher reoperation rate. Survival time was significantly lower in L5-6 (47 vs. 22 months, p = 0.002) and two-level DIAM TM implantation (46 vs. 18 months, p = 0.01) compared with L4-5 and one-level DIAM TM implantation. The current results suggest that 8% of the patients who have a DIAM TM implantation for primary lumbar spinal stenosis or disc herniation are expected to undergo reoperation at the same level within 4 years after surger...

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“…Several studies in patients with neurogenic claudication and back pain showed that treatment with interspinous spacers led to significant improvements in patients' ability to walk. A collateral finding in these patients was an improvement in both claudication and LBP [4,9,11,20,23,26].…”

Section: Introductionmentioning

confidence: 82%

Long-term reduction in pain and disability after surgery with the interspinous device for intervertebral assisted motion (DIAM) spinal stabilization system in patients with low back pain: 4-year follow-up from a longitudinal prospective case series

Buric¹,

Pulidori²

2011

Eur Spine J

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Patients with low back pain (LBP) suffer chronic disability. In 40% of LBP patients degenerative disc disease (DDD) seems to be the cause. This prospective case series assessed the efficacy of the interspinous device for intervertebral assisted motion (DIAM TM ) in patients with LBP resulting from DDD. All patients were initially assessed by physical examinations, magnetic resonance imaging, dynamic X-rays and provocative discography. Eligible patients (n = 52) had LBP for a minimum of 4 months, and received surgery with the DIAM TM system 2-4 weeks after diagnosis. Patients were evaluated pre-/ post-operatively for pain severity using a visual analogue scale (VAS), and for dysfunction and disability with the Roland-Morris Disability Questionnaire (RMDQ). VAS and RMDQ score changes were assessed using the appropriate contrasts and Bonferroni-corrected P values. As a result, significant (P \ 0.0001) pain score reductions were observed between baseline values, and 2 (3.7, 95% CI 3.1; 4.2) and 48 (3.1, 95% CI 2.5; 3.6) months follow-up (intent-to-treat population). Disability scores were significantly (P \ 0.0001) reduced between baseline and 2 (8.6, 95% CI 7.4; 9.9) and 48 (7.5, 95% CI 6.1; 8.9) months. Disability scores were similar from months 2 to 48. At 48 months, 67.3% of patients reached the minimum clinically important difference (MCID; C1.5-unit improvement) in VAS score and 78.9% of patients reached the MCID (C30% improvement) in RMDQ score. No complications were associated with surgery. In conclusion, patients with LBP treated with the interspinous DIAM TM system showed significant and clinically meaningful improvements in pain and disability for up to 4 years.

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Dynamic stabilization devices in the treatment of low back pain

Cited by 144 publications

References 57 publications

Dynamic stabilization adjacent to single-level fusion: Part I. Biomechanical effects on lumbar spinal motion

Dynamic stabilization adjacent to single-level fusion: Part I. Biomechanical effects on lumbar spinal motion

Survivorship analysis of 150 consecutive patients with DIAM™ implantation for surgery of lumbar spinal stenosis and disc herniation

Long-term reduction in pain and disability after surgery with the interspinous device for intervertebral assisted motion (DIAM) spinal stabilization system in patients with low back pain: 4-year follow-up from a longitudinal prospective case series

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