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Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3 (LOPAIN3)

Primary Purpose

Back Pain With Radiation, Radiculopathy, Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
PerQdisc Nucleus Replacement System
Sponsored by
Spinal Stabilization Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain With Radiation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is skeletally mature and at least 21 years of age. Patient has a lumbar disc herniation, between L1-S1, with compressive radiculopathy of the traversing nerve root requiring partial discectomy or sequestrectomy. Only one lumbar disc may be treated with the PerQdisc device. Patient must have an overall disc herniation (extrusion or protrusion) such that half or less of the width of the dorsal annulus of the spinal canal, is affected by the herniation. The width of the canal is defined by the lateral recesses and the central canal (i.e. pedicle to pedicle). Patient must have a minimum of 6 mm of disc height as measured in the center of the affected disc. Patient is willing and able to give informed consent. All surgeries must be approved by at least 2 members of the Medical Advisory Board (MAB) - potential anatomical limitations of safely accessing Kambin's, extent of annular disruption, as well as overall patient criteria will be evaluated Exclusion Criteria: Patient has had prior lumbar spine surgery at the index level (nucleoplasy is acceptable). Patient has had spinal fusion in the lumbar spine. Cervical or thoracic fusion is allowed as long as there are no neurologic deficits in the lower extremities. Patient has spondyloarthropathy or other spondylolisthesis greater than 4 mm or spondylolysis at the index level (on standing X-ray). Patient has underlying moderate or severe spinal stenosis (congenital, degenerative, or due to epidural lipomatosis) at any level. If the index level shows stenosis due to the disc herniation, it is acceptable if the index level is going to be treated concurrently with the PerQdsic procedure. Patient has compressive radiculopathy of the exiting nerve root at the index level. Patient has significant facet disease. Significant is defined as clinically confirmed by diagnostic block or radiologically grade 2 or higher (mild joint narrowing and irregularity are acceptable, but not sclerosis or osteophyte formation). Patient has any known active malignancy. Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed. Patient has active local or systemic infection. Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, AIDS related complex (ARC) and HIV. Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management. Patient has osteopenia of the spine (T-score of -1.0 or lower). All patients 50 years of age or older, and any post menopausal women with a history of fractures should have a dual x-ray absorptiometry (DEXA) scan to confirm exclusion. Patient has morbid obesity defined as a body mass index (BMI) more than 35 (>35). Patient has a known allergy to silicone or barium sulfate. Patient has a broad disc herniation that is wider than ½ of the dorsal annulus forming the wall of the spinal canal Patient requires decompression involving disruption of the midline bony-ligamentous elements (i.e. laminectomy). Patient has a significant Schmorl's node at the level to be treated, or any Schmorl's nodes affecting 3 or more lumbar levels. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes). Patient has more than 20 degrees of mobility on flexion/extension radiographs at the index level Patient has more than 10 degrees of lumbar scoliosis. Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser) Patient is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by serum HCG. If patient becomes pregnant during the course of the study and wishes to continue study participation, a new Pregnancy Informed Consent must be completed. Intraoperative Exclusion: Poor radiological visualization of Kambin's triangle Patient has annular defect following surgical treatment of the disc herniation/protrusion that is greater than 6 mm Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite of repositioning instruments. Protrusion of the 50A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps. Patient has a violated endplate as determined by imaging balloons during fluoroscopy.

Sites / Locations

  • Sanatorio AmericanoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumbar Disc Nucleus Replacement following discectomy

Arm Description

All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.

Outcomes

Primary Outcome Measures

Safety: Number of Patients with Serious Adverse Events related to the PerQdisc
Freedom from device- and procedure-related serious adverse events definitely related to the PerQdisc Device or the PerQdisc Surgical Procedure

Secondary Outcome Measures

Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator

Full Information

First Posted
January 30, 2023
Last Updated
February 7, 2023
Sponsor
Spinal Stabilization Technologies
Collaborators
Raylytic GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05732818
Brief Title
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3
Acronym
LOPAIN3
Official Title
Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy "LOPAIN3"
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
November 4, 2026 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spinal Stabilization Technologies
Collaborators
Raylytic GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.
Detailed Description
The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects. Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain With Radiation, Radiculopathy, Back Pain, Disc Herniation, Herniated Nucleus Pulposus, Herniated Disc, Disc Injury, Disk Herniated Lumbar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB).
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumbar Disc Nucleus Replacement following discectomy
Arm Type
Experimental
Arm Description
All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.
Intervention Type
Device
Intervention Name(s)
PerQdisc Nucleus Replacement System
Intervention Description
Lumbar spine disc nucleus replacement system. All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.
Primary Outcome Measure Information:
Title
Safety: Number of Patients with Serious Adverse Events related to the PerQdisc
Description
Freedom from device- and procedure-related serious adverse events definitely related to the PerQdisc Device or the PerQdisc Surgical Procedure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Performance: ODI
Description
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time Frame
3 months
Title
Performance: ODI
Description
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time Frame
6 months
Title
Performance: ODI
Description
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time Frame
12 months
Title
Performance: ODI
Description
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time Frame
24 months
Title
Performance: VAS Back
Description
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
3 months
Title
Performance: VAS Back
Description
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
6 months
Title
Performance: VAS Back
Description
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
12 months
Title
Performance: VAS Back
Description
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
24 months
Title
Performance: VAS Leg
Description
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
3 months
Title
Performance: VAS Leg
Description
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
6 months
Title
Performance: VAS Leg
Description
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
12 months
Title
Performance: VAS Leg
Description
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time Frame
24 months
Title
Performance: Analgesic Score
Description
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time Frame
3 months
Title
Performance: Analgesic Score
Description
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time Frame
6 months
Title
Performance: Analgesic Score
Description
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time Frame
12 months
Title
Performance: Analgesic Score
Description
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time Frame
24 months
Title
Safety: Number of Patients with Reherniation/recurrent disc herniation
Description
Freedom from reherniation/recurrent disc herniation
Time Frame
3 months
Title
Safety: Number of Patients with Reherniation/recurrent disc herniation
Description
Freedom from reherniation/recurrent disc herniation
Time Frame
6 months
Title
Safety: Number of Patients with Reherniation/recurrent disc herniation
Description
Freedom from reherniation/recurrent disc herniation
Time Frame
12 months
Title
Safety: Number of Patients with Reherniation/recurrent disc herniation
Description
Freedom from reherniation/recurrent disc herniation
Time Frame
24 months
Title
Safety: Number of Patient that Received Supplemental fixation
Description
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time Frame
3 months
Title
Safety: Number of Patient that Received Supplemental fixation
Description
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time Frame
6 months
Title
Safety: Number of Patient that Received Supplemental fixation
Description
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time Frame
12 months
Title
Safety: Number of Patient that Received Supplemental fixation
Description
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Exploratory Endpoint: Disch Height
Description
Disc height in millimeters at each clinical visit as measured on plain film X-ray
Time Frame
3 months
Title
Exploratory Endpoint: Disch Height
Description
Disc height in millimeters at each clinical visit as measured on plain film X-ray
Time Frame
6 months
Title
Exploratory Endpoint: Disch Height
Description
Disc height in millimeters at each clinical visit as measured on plain film X-ray
Time Frame
12 months
Title
Exploratory Endpoint: Disch Height
Description
Disc height in millimeters at each clinical visit as measured on plain film X-ray
Time Frame
24 months
Title
Exploratory Endpoint: RoM
Description
Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
Time Frame
3 months
Title
Exploratory Endpoint: RoM
Description
Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
Time Frame
6 months
Title
Exploratory Endpoint: RoM
Description
Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
Time Frame
12 months
Title
Exploratory Endpoint: RoM
Description
Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
Time Frame
24 months
Title
Exploratory Endpoint: Neurological Status
Description
Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale
Time Frame
3 months
Title
Exploratory Endpoint: Neurological Status
Description
Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale
Time Frame
6 months
Title
Exploratory Endpoint: Neurological Status
Description
Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale
Time Frame
12 months
Title
Exploratory Endpoint: Neurological Status
Description
Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is skeletally mature and at least 21 years of age. Patient has a lumbar disc herniation, between L1-S1, with compressive radiculopathy of the traversing nerve root requiring partial discectomy or sequestrectomy. Only one lumbar disc may be treated with the PerQdisc device. Patient must have an overall disc herniation (extrusion or protrusion) such that half or less of the width of the dorsal annulus of the spinal canal, is affected by the herniation. The width of the canal is defined by the lateral recesses and the central canal (i.e. pedicle to pedicle). Patient must have a minimum of 6 mm of disc height as measured in the center of the affected disc. Patient is willing and able to give informed consent. All surgeries must be approved by at least 2 members of the Medical Advisory Board (MAB) - potential anatomical limitations of safely accessing Kambin's, extent of annular disruption, as well as overall patient criteria will be evaluated Exclusion Criteria: Patient has had prior lumbar spine surgery at the index level (nucleoplasy is acceptable). Patient has had spinal fusion in the lumbar spine. Cervical or thoracic fusion is allowed as long as there are no neurologic deficits in the lower extremities. Patient has spondyloarthropathy or other spondylolisthesis greater than 4 mm or spondylolysis at the index level (on standing X-ray). Patient has underlying moderate or severe spinal stenosis (congenital, degenerative, or due to epidural lipomatosis) at any level. If the index level shows stenosis due to the disc herniation, it is acceptable if the index level is going to be treated concurrently with the PerQdsic procedure. Patient has compressive radiculopathy of the exiting nerve root at the index level. Patient has significant facet disease. Significant is defined as clinically confirmed by diagnostic block or radiologically grade 2 or higher (mild joint narrowing and irregularity are acceptable, but not sclerosis or osteophyte formation). Patient has any known active malignancy. Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed. Patient has active local or systemic infection. Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, AIDS related complex (ARC) and HIV. Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management. Patient has osteopenia of the spine (T-score of -1.0 or lower). All patients 50 years of age or older, and any post menopausal women with a history of fractures should have a dual x-ray absorptiometry (DEXA) scan to confirm exclusion. Patient has morbid obesity defined as a body mass index (BMI) more than 35 (>35). Patient has a known allergy to silicone or barium sulfate. Patient has a broad disc herniation that is wider than ½ of the dorsal annulus forming the wall of the spinal canal Patient requires decompression involving disruption of the midline bony-ligamentous elements (i.e. laminectomy). Patient has a significant Schmorl's node at the level to be treated, or any Schmorl's nodes affecting 3 or more lumbar levels. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes). Patient has more than 20 degrees of mobility on flexion/extension radiographs at the index level Patient has more than 10 degrees of lumbar scoliosis. Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser) Patient is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by serum HCG. If patient becomes pregnant during the course of the study and wishes to continue study participation, a new Pregnancy Informed Consent must be completed. Intraoperative Exclusion: Poor radiological visualization of Kambin's triangle Patient has annular defect following surgical treatment of the disc herniation/protrusion that is greater than 6 mm Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite of repositioning instruments. Protrusion of the 50A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps. Patient has a violated endplate as determined by imaging balloons during fluoroscopy.
Facility Information:
Facility Name
Sanatorio Americano
City
Asunción
ZIP/Postal Code
1101
Country
Paraguay
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Cetraro
Phone
+595 981524485
Email
radiosolutionspy@gmail.com
First Name & Middle Initial & Last Name & Degree
Francisco Duarte, MD

12. IPD Sharing Statement

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Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3

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