Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis

NCT05587465 | Unknown

• 1 other identifier: 446/2022/CE
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.

Conditions

Spinal Lumbar Stenosis; Claudication, Intermittent

Keywords

Radiology; Interspinous Spacer; Interventional Radiology; Neurosurgery; Vertebral surgery; Pain management; Neurogenic intermittent claudicatio; Degenerative disc disease; Percutaneous operating technique

Outcome Measures

Primary Outcomes (2)

• Effectiveness of the Lobster device in comparison to an SSED-based performance goal (PG)

  Efficacy success will be evaluated as a two-prong composite endpoint: * ZCQ Responder (at least two of the three ZCQ domains) * ≥0.5 point improvement in physical function * ≥0.5 point improvement in symptom severity * Mean satisfaction ≤2.5 points * No secondary surgical intervention (SSI) including re-operations, revision, removals or supplemental fixation or clinical significant confounding treatments (i.e., epidural steroid injections at the index level, spinal cord stimulators or rhizotomies) through 12 months

  12 months

• Safety of the Lobster device in comparison to an SSED-based performance goal (PG)

  Safety success will be evaluated using precision-based statistics to characterize the incidence of major device- or procedure-related complications, including: * Device integrity failure (dislodgement, migration, or deformation) * New or persistent worsened neurological deficit at the index level * Spinous process fractures * Deep infection, death, or other permanent device attributed disability

  12 months

Secondary Outcomes (6)

• Oswestry disability index (ODI)

  Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months

• Visual Analogue Scale (VAS)

  Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months

• Short Form SF-12

  Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months

• Zurich Claudication Questionnaire (ZCQ)

  Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months

• Number of participants with abnormal Neurological examination findings

  Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months

Study Arms (1)

Treatment

EXPERIMENTAL

Lobster device implantation

Device: Lobster Device

Interventions

Lobster Device DEVICE

The intervention is performed percutaneously using the dedicated instrument set.

Also known as: Interspinous Spacer implantation

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 45 years of age.
• Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart).
• Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months.
• Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal).
• Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as 25% to 50% reduction in lateral/central foramen compared to the adjacent levels, with radiographic confirmation of any one of the following:
• Evidence of thecal sac and/or cauda equina compression.
• Evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
• Evidence of hypertrophic facets with canal encroachment.
• Note: All imaging studies used to confirm LSS are to be completed within 3 months prior to enrollment. Radiographic (imaging) confirmation of LSS included MRI and/or CT. In the case of a transitional L5/L6 segment with a sufficiently prominent L6 spinous process, these subjects may be included by a deviation request from the applicant.
• Must present with moderately impaired Physical Function (PF) defined as a score of \> 2.0 of the Zurich Claudication Questionnaire (ZCQ).
• Must be able to sit for 50 minutes without pain and to walk 15 meters (50 feet) or more .
• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.

You may not qualify if:

• Axial back pain only.
• Fixed motor deficit.
• Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or investigational device.
• Unremitting pain in any spinal position.
• Significant peripheral neuropathy or acute denervation secondary to radiculopathy.
• Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention.
• Significant instability of the lumbar spine as defined by ≥ 3mm translation or ≥ 5° angulation.
• Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.
• Spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1-4).
• Spondylolysis (pars fracture).
• Degenerative lumbar scoliosis with a Cobb angle of \> 10° at treatment level.
• Osteopenia or osteoporosis. To confirm eligibility, at the Clinical Investigator's discretion, the following subjects may have a DEXA scan performed:
• Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2.
• Insulin-dependent diabetes mellitus.
• Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses).

Sponsors & Collaborators

• Diametros Medical srl: lead
• MCRA: collaborator
• Sciently di Omar Sabry: collaborator
• Medical Consulting srl: collaborator

Study Sites (1)

SS. Trinità - Reparto di Radiologia

Cagliari, Sardinia, 09121, Italy

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication; Agnosia; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Garlatti

CONTACT

+39 338 784 5689; g.garlatti@diametrosmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm, prospective, multicenter study

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: October 5, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

IT (1)