Dataset Information

Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?

ABSTRACT:

Background

Standalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature.

Objective

To show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC.

Methods

A multicenter, international, randomized, controlled trial (RCT) was con- ducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo.

Results

There was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (-32.3 ± 32.1, -37.5 ± 22.8; and -37.9 ± 21.7%, -35.2 ± 22.8, both P < .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12 mo (P = .172) but was significantly noninferior at 24 mo (P = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time and mean blood loss (24 ± 11 min and 6 ± 11 mL) compared to SDS (70 ± 39 min and 189 ± 148 mL, both P < .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3% in the SDS group.

Conclusion

Confirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.

SUBMITTER: Meyer B

PROVIDER: S-EPMC6018837 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Publications

Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?

Meyer Bernhard B Baranto Adad A Schils Frederic F Collignon Frederic F Zoega Bjorn B Tan Leong L LeHuec Jean-Charles JC

Neurosurgery 20180501 5

<h4>Background</h4>Standalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature.<h4>Objective</h4>To show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC.<h4>Methods</h4>A multicenter, international, randomized, controlled trial (RCT) was con- ducted ...[more]

PMID: 28973638

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Project description:Background and objectivesThis study evaluated the long-term durability of the minimally invasive lumbar decompression (MILD) procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This is a report of 2-year follow-up for MILD study patients.MethodsThis prospective, multicenter, randomized controlled clinical study compared outcomes for 143 patients treated with MILD versus 131 treated with epidural steroid injections. Follow-up occurred at 6 months and at 1 year for the randomized phase and at 2 years for MILD subjects only. Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire were used to evaluate function and pain. Safety was evaluated by assessing incidence of device-/procedure-related adverse events.ResultsAll outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through 6-month, 1-year, and 2-year follow-ups. At 2 years, Oswestry Disability Index improved by 22.7 points, Numeric Pain Rating Scale improved by 3.6 points, and Zurich Claudication Questionnaire symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. There were no serious device-/procedure-related adverse events, and 1.3% experienced a device-/procedure-related adverse event.ConclusionsMILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are lower, and safety is higher for MILD versus other lumbar spine interventions, including interspinous spacers, surgical decompression, and spinal fusion. Given the minimally invasive nature of this procedure, its robust success rate, and durability of outcomes, MILD is an excellent choice for first-line therapy for select patients with central spinal stenosis suffering from neurogenic claudication symptoms with hypertrophic ligamentum flavum.Clinical trial registrationThis study was registered at ClinicalTrials.gov, identifier NCT02093520.

Dataset Information

Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?

Background

Objective

Methods

Results

Conclusion

Publications

Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?

Similar Datasets

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