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

Claudication, Intermittent Clinical Trial

— LB2CT01  

Official title:

Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis: A Single Arm, Prospective, Mutli-Center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587465
• Other study ID #: 446/2022/CE
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2022
• Source: Diametros Medical srl
• Contact: Garlatti
• Phone: +39 338 784 5689
• Email: g.garlatti[@]diametrosmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After being informed about the study and potential risks, patients with Lumbar Spinal Stenosis matching inclusion and exclusion criteria giving written informed consent will undergo Lobster device implantation and followed-up for 2 years for radiological and clinical assessment in a single-arm, prospective, multicentric clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects = 45 years of age.

2. Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart).

3. Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months.

4. 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).

5. 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:

1. Evidence of thecal sac and/or cauda equina compression.

2. Evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.

3. 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.

6. Must present with moderately impaired Physical Function (PF) defined as a score of > 2.0 of the Zurich Claudication Questionnaire (ZCQ).

7. Must be able to sit for 50 minutes without pain and to walk 15 meters (50 feet) or more .

8. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

9. 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.

Exclusion Criteria:

1. Axial back pain only.

2. Fixed motor deficit.

3. 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.

4. Unremitting pain in any spinal position.

5. Significant peripheral neuropathy or acute denervation secondary to radiculopathy.

6. Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention.

7. Significant instability of the lumbar spine as defined by = 3mm translation or = 5° angulation.

8. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.

9. Spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1-4).

10. Spondylolysis (pars fracture).

11. Degenerative lumbar scoliosis with a Cobb angle of > 10° at treatment level.

12. Osteopenia or osteoporosis. To confirm eligibility, at the Clinical Investigator's discretion, the following subjects may have a DEXA scan performed: i. Women 65 or older ii. Postmenopausal women < age 65 iii. Subjects with major risk factors for or diagnosed with osteoporosis or osteopenia iv. If DEXA is required, exclusion is defined as a DEXA bone density measurement T score = -2.5

13. Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2.

14. Insulin-dependent diabetes mellitus.

15. Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses).

16. Prior surgery of the lumbar spine.

17. Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).

18. Infection in the disc or spine, past or present.

19. Evidence of active (systemic or local) infection at time of surgery.

20. Active systemic disease such as AIDS, HIV, hepatitis, etc.

21. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease.

22. Currently undergoing immunosuppressive therapy or long-term steroid use.

23. Known allergy to titanium or titanium alloys.

24. Tumor in the spine or a malignant tumor except for basal cell carcinoma 25. Known or suspected history of alcohol and/or drug abuse.

25. Prisoner or transient.

26. Life expectancy less than two years.

27. Angina, active rheumatoid arthritis, or any other systemic disease that would affect the subject's welfare or outcome of the clinical investigation.

28. Any significant mental illness (e.g., major depression, schizophrenia, bipolar disorder, etc.) that could impair the consent process or ability to complete subject self-report questionnaires.

29. Involved in pending litigation of the spine or worker's compensation related to the back.

30. Enrolled in the treatment phase of another drug or device clinical investigation (currently or within past 30 days).

31. Congenital defect of the spine.

32. Pregnant or lactating.

33. Any further contraindications and limitations of the device as described in the instructions for use (IFU). Subjects who meet any of the following criteria will be excluded from participating in this

study:

1. Axial back pain only.

2. Fixed motor deficit.

3. 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.

4. Unremitting pain in any spinal position.

5. Significant peripheral neuropathy or acute denervation secondary to radiculopathy.

6. Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention.

7. Significant instability of the lumbar spine as defined by = 3mm translation or = 5° angulation.

8. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.

9. Spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1-4).

10. Spondylolysis (pars fracture).

11. Degenerative lumbar scoliosis with a Cobb angle of > 10° at treatment level.

12. Osteopenia or osteoporosis. To confirm eligibility, at the Clinical Investigator's discretion, the following subjects may have a DEXA scan performed: i. Women 65 or older ii. Postmenopausal women < age 65 iii. Subjects with major risk factors for or diagnosed with osteoporosis or osteopenia iv. If DEXA is required, exclusion is defined as a DEXA bone density measurement T score = -2.5

13. Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2.

14. Insulin-dependent diabetes mellitus.

15. Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses).

16. Prior surgery of the lumbar spine.

17. Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).

18. Infection in the disc or spine, past or present.

19. Evidence of active (systemic or local) infection at time of surgery.

20. Active systemic disease such as AIDS, HIV, hepatitis, etc.

21. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease.

22. Currently undergoing immunosuppressive therapy or long-term steroid use.

23. Known allergy to titanium or titanium alloys.

24. Tumor in the spine or a malignant tumor except for basal cell carcinoma 25. Known or suspected history of alcohol and/or drug abuse.

25. Prisoner or transient.

26. Life expectancy less than two years.

27. Angina, active rheumatoid arthritis, or any other systemic disease that would affect the subject's welfare or outcome of the clinical investigation.

28. Any significant mental illness (e.g., major depression, schizophrenia, bipolar disorder, etc.) that could impair the consent process or ability to complete subject self-report questionnaires.

29. Involved in pending litigation of the spine or worker's compensation related to the back.

30. Enrolled in the treatment phase of another drug or device clinical investigation (currently or within past 30 days).

31. Congenital defect of the spine.

32. Pregnant or lactating.

33. Any further contraindications and limitations of the device as described in the instructions for use (IFU).

Related Conditions & MeSH terms

• Claudication, Intermittent
• Constriction, Pathologic
• Intermittent Claudication
• Spinal Stenosis

Intervention

Device:
• Lobster Device
The intervention is performed percutaneously using the dedicated instrument set.

Locations

Country	Name	City	State
Italy	SS. Trinità - Reparto di Radiologia	Cagliari	Sardegna

Sponsors (4)

Lead Sponsor	Collaborator
Diametros Medical srl	MCRA, Medical Consulting srl, Sciently di Omar Sabry

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Oswestry disability index (ODI)	Oswestry disability index. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.; Min. value 0 (better outcome) Max. value 100 (worst outcome)	Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary	Visual Analogue Scale (VAS)	VAS (Pain regarding Back and Leg); Min. value 0 (better outcome) Max. value 10 (worst outcome)	Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary	Short Form SF-12	SF-12 Short Form Survey (Physical Function and Mental Health). The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.; Min. value 0 (worst outcome) Max. value 100 (better outcome)	Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary	Zurich Claudication Questionnaire (ZCQ)	The questionnaire consists of three domains and uses a Likert-type scale. It includes 7 items for symptom severity with scores of 1 to 5, 5 items for functional disability with scores of 1 to 4, and 6 items for treatment satisfaction with score of 1 to 4. Higher scores indicate more severe LSS.	Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary	Number of participants with abnormal Neurological examination findings	Neurological examination to assess and identify any abnormalities that affect function and activities of daily living. Electromyography is performed at the discretion of the investigator.	Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary	Radiological status	An independent radiographic core laboratory will be used to provide an unbiased assessment of all x-rays and CT scans (pre-procedure through last follow-up assessment). All images will be evaluated in accordance with the Image Review Charter which is provided to the sites.; Radiographic evaluations include: Angular Range of Motion; Translational Motion; Device Condition; Device Migration; Device Dislodgement; Bone-Implant Interface Changes; Exuberant Bone Formation	Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months