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Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (MODEL)

Primary Purpose

Lumbar Degenerative Disc Disease

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SB-01 For Injection
Sham Needle
Sponsored by
Spine BioPharma, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Degenerative Disc Disease

Eligibility Criteria

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

Inclusion Criteria:

  1. 18 years of age or older
  2. Back pain greater than 'worst leg pain' as measured by the NRS
  3. Diagnosed with one or two contiguous level(s) lumbar (L1-S1) disc degeneration of Pfirrmann Grade 3 and/or 4 determined by MRI analyzed by the independent radiologic central lab
  4. Have chronic low back pain and related disability for at least 6 months with at least 3 months of prior conservative treatment
  5. Baseline ODI score ≥ 40/100
  6. Baseline NRS ≥ 4 points (Back)
  7. Willing and able to provide Informed Consent for study participation
  8. Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet
  9. Must practice effective contraception during the first 3 months of follow-up (female of childbearing potential and male subjects):

    1. Abstinence or,
    2. Surgical Sterilization or,
    3. Oral Contraceptives or,
    4. Barrier Methods (Condoms, IUD's).
  10. Patient must verify that:

    1. In the case of females, the patient is post-menopausal or is surgically sterile or,
    2. In the case of males, the patient is surgically sterile or,
    3. The patient (male or female) confirms that they are at a point in their life where they are beyond consideration of having children.

Exclusion Criteria:

To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.

  1. Prior epidural, sacroiliac joint, or facet injections at any lumbosacral level within the past 4 weeks (e.g., transforaminal, interlaminar, caudal)
  2. Prior interventional procedures of other types at any lumbosacral level at any time (e.g., intradiscal injection, basivertebral nerve ablation, biacuplasty; radiofrequency (RF) ablation, spinal cord stimulator, others)
  3. Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others)
  4. Prior fracture at any lumbar level
  5. Significant neurologic symptoms:

    1. Grade 3/5 or lower strength in any lumbar myotome
    2. Sensory deficit in a clearly radicular or sensory dermatome
  6. MRI evidence of disc height loss > 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab
  7. MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab
  8. MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab
  9. MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab
  10. MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab
  11. MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab
  12. Spondylolisthesis (antero or retrolisthesis) > 25% at any level, determined by the independent radiologic central lab
  13. Lumbar coronal deformity, determined by the independent radiologic central lab:

    a. L1-S1 regional deformity > 25 degrees

  14. Spondylolysis at any level
  15. Lumbar inflammatory spondylitis
  16. Recent history (previous six months) of chemical or alcohol dependence
  17. Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs)
  18. Depression or Somatization defined through the Distress and Risk Assessment Method (DRAM) scoring with Zung score > 33 or Zung > 17 and the Modified Somatic Perception Questionnaire (MSPQ) score > 12
  19. Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
  20. A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 470 millisecond (msec)
  21. Active systemic infection
  22. Infection at the site of procedure pre-operatively
  23. Cauda equina syndrome or neurogenic bowel/bladder dysfunction
  24. Any terminal, systemic, or autoimmune disease including fibromyalgia, which may, in the opinion of the Principal Investigator compromise a subject's ability to comply with study procedures, and/or confound data
  25. Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease)
  26. Any disease, condition or surgery which might impair healing, such as:

    1. Active malignancy
    2. History of metastatic malignancy
  27. Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
  28. Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit)
  29. Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels
  30. Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up
  31. Currently a prisoner
  32. Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure
  33. Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation
  34. Patient cannot be currently using the prohibited medications listed in the protocol

Sites / Locations

  • Evolve Clinical ResearchRecruiting
  • Arizona Pain
  • Southern California (SC) Spine and Sport Medical Associates, Inc.Recruiting
  • Central Coast Neurological SurgeryRecruiting
  • Source HealthcareRecruiting
  • Science Connections, LLCRecruiting
  • Coastal Clinical ResearchRecruiting
  • Pain Relief CentersRecruiting
  • Tampa Pain Relief CenterRecruiting
  • Florida Pain Relief GroupRecruiting
  • Conquest ResearchRecruiting
  • Vista Clinical Research, LLCRecruiting
  • Injury Care ResearchRecruiting
  • Duly HealthRecruiting
  • The Orthopaedic Research Foundation, Inc (OrthoIndy)Recruiting
  • Abay Neuroscience CenterRecruiting
  • Spine Institute of LouisianaRecruiting
  • Pain Management Center, Brigham and Women's HospitalRecruiting
  • OrthoNebraskaRecruiting
  • Ainsworth Institute of Pain ManagementRecruiting
  • META Medical Research InstituteRecruiting
  • Kettering HealthRecruiting
  • Clinical Investigations LLC
  • The Orthopedic CenterRecruiting
  • HD ResearchRecruiting
  • NeuroCare PartnersRecruiting
  • South Texas Spinal ClinicRecruiting
  • Precision Spine CareRecruiting
  • Virginia iSpine PhysiciansRecruiting
  • Gershon Pain SpecialistsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SB-01 For Injection

Sham Needle

Arm Description

Subjects receive a SB-01 For Injection intradiscal injection per treated disc.

Subjects receive a sham needle placement for each treated disc.

Outcomes

Primary Outcome Measures

Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months.
The ODI is a validated, 10-item self-reported instrument assessment of pain-related disability. Possible scores range from 0 (no disability) - 50 (severe disability). Further calculations are applied to reach a percentage score.

Secondary Outcome Measures

Change from Baseline in pain on the Numerical Rating Scale (NRS) at 6 months. This outcome will only be tested if the primary endpoint is met.
The NRS is an 11-point scale, self-reported instrument assessment of pain intensity ranging across a continuum from no pain to an extreme amount of pain. The NRS will be collected for: Back and both legs. A lower score indicates less pain.

Full Information

First Posted
August 24, 2022
Last Updated
October 18, 2023
Sponsor
Spine BioPharma, Inc
Collaborators
MCRA
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1. Study Identification

Unique Protocol Identification Number
NCT05516992
Brief Title
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
Acronym
MODEL
Official Title
A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety and Efficacy of SB-01 For Injection for the Treatment of Lumbar Degenerative Disc Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spine BioPharma, Inc
Collaborators
MCRA

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind, placebo-controlled study.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SB-01 For Injection
Arm Type
Experimental
Arm Description
Subjects receive a SB-01 For Injection intradiscal injection per treated disc.
Arm Title
Sham Needle
Arm Type
Placebo Comparator
Arm Description
Subjects receive a sham needle placement for each treated disc.
Intervention Type
Drug
Intervention Name(s)
SB-01 For Injection
Intervention Description
Intradiscal injection
Intervention Type
Drug
Intervention Name(s)
Sham Needle
Intervention Description
Sham needle placement
Primary Outcome Measure Information:
Title
Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months.
Description
The ODI is a validated, 10-item self-reported instrument assessment of pain-related disability. Possible scores range from 0 (no disability) - 50 (severe disability). Further calculations are applied to reach a percentage score.
Time Frame
Baseline/Screening and 6 Month
Secondary Outcome Measure Information:
Title
Change from Baseline in pain on the Numerical Rating Scale (NRS) at 6 months. This outcome will only be tested if the primary endpoint is met.
Description
The NRS is an 11-point scale, self-reported instrument assessment of pain intensity ranging across a continuum from no pain to an extreme amount of pain. The NRS will be collected for: Back and both legs. A lower score indicates less pain.
Time Frame
Baseline/Screening and 6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Back pain greater than 'worst leg pain' as measured by the NRS Diagnosed with one or two contiguous level(s) lumbar (L1-S1) disc degeneration of Pfirrmann Grade 3 and/or 4 determined by MRI analyzed by the independent radiologic central lab Have chronic low back pain and related disability for at least 6 months with at least 3 months of prior conservative treatment Baseline ODI score ≥ 40/100 Baseline NRS ≥ 4 points (Back) Willing and able to provide Informed Consent for study participation Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet Must practice effective contraception during the first 3 months of follow-up (female of childbearing potential and male subjects): Abstinence or, Surgical Sterilization or, Oral Contraceptives or, Barrier Methods (Condoms, IUD's). Patient must verify that: In the case of females, the patient is post-menopausal or is surgically sterile or, In the case of males, the patient is surgically sterile or, The patient (male or female) confirms that they are at a point in their life where they are beyond consideration of having children. Exclusion Criteria: To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows. Prior epidural, sacroiliac joint, or facet injections at any lumbosacral level within the past 4 weeks (e.g., transforaminal, interlaminar, caudal) Prior interventional procedures of other types at any lumbosacral level at any time (e.g., intradiscal injection, basivertebral nerve ablation, biacuplasty; radiofrequency (RF) ablation, spinal cord stimulator, others) Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others) Prior fracture at any lumbar level Significant neurologic symptoms: Grade 3/5 or lower strength in any lumbar myotome Sensory deficit in a clearly radicular or sensory dermatome MRI evidence of disc height loss > 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab Spondylolisthesis (antero or retrolisthesis) > 25% at any level, determined by the independent radiologic central lab Lumbar coronal deformity, determined by the independent radiologic central lab: a. L1-S1 regional deformity > 25 degrees Spondylolysis at any level Lumbar inflammatory spondylitis Recent history (previous six months) of chemical or alcohol dependence Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs) Depression or Somatization defined through the Distress and Risk Assessment Method (DRAM) scoring with Zung score > 33 or Zung > 17 and the Modified Somatic Perception Questionnaire (MSPQ) score > 12 Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI > 40) A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 470 millisecond (msec) Active systemic infection Infection at the site of procedure pre-operatively Cauda equina syndrome or neurogenic bowel/bladder dysfunction Any terminal, systemic, or autoimmune disease including fibromyalgia, which may, in the opinion of the Principal Investigator compromise a subject's ability to comply with study procedures, and/or confound data Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease) Any disease, condition or surgery which might impair healing, such as: Active malignancy History of metastatic malignancy Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit) Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up Currently a prisoner Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation Patient cannot be currently using the prohibited medications listed in the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Zicker, NP
Phone
831-239-4115
Email
pzicker@spinebiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Gilligan, MD, MBA
Organizational Affiliation
Brigham and Women's Spine Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evolve Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Rodriguez
First Name & Middle Initial & Last Name & Degree
Zeeshan Malik, MD
Facility Name
Arizona Pain
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Withdrawn
Facility Name
Southern California (SC) Spine and Sport Medical Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660-7641
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandra Smith
First Name & Middle Initial & Last Name & Degree
Richard Paicius, MD
Facility Name
Central Coast Neurological Surgery
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dee Tran
First Name & Middle Initial & Last Name & Degree
David Yeh, MD
Facility Name
Source Healthcare
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Nguyen
First Name & Middle Initial & Last Name & Degree
Timothy Davis, MD
Facility Name
Science Connections, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33178
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Olivera
First Name & Middle Initial & Last Name & Degree
Santiago Figuereo, MD
Facility Name
Coastal Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lew Whiting
First Name & Middle Initial & Last Name & Degree
Christopher Netzel, MD
Facility Name
Pain Relief Centers
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shellie Reader
First Name & Middle Initial & Last Name & Degree
Robert Guirguis, MD
Facility Name
Tampa Pain Relief Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Wood
First Name & Middle Initial & Last Name & Degree
Jose Rivera, MD
Facility Name
Florida Pain Relief Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiset Sanchez
First Name & Middle Initial & Last Name & Degree
Jorge Leal, MD
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Conte
First Name & Middle Initial & Last Name & Degree
Malisa Agard, MD
Facility Name
Vista Clinical Research, LLC
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Helton
First Name & Middle Initial & Last Name & Degree
Ashley Miller, NP
Facility Name
Injury Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Heinz
First Name & Middle Initial & Last Name & Degree
Richard Radnovich, DO
Facility Name
Duly Health
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Carrington
First Name & Middle Initial & Last Name & Degree
Ashish Patel, MD
Facility Name
The Orthopaedic Research Foundation, Inc (OrthoIndy)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Glover
First Name & Middle Initial & Last Name & Degree
Meredith Langhorst, MD
Facility Name
Abay Neuroscience Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Welty
First Name & Middle Initial & Last Name & Degree
Raymond Grundmeyer III, MD
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Casey
First Name & Middle Initial & Last Name & Degree
Matthew Mosura, MD
Facility Name
Pain Management Center, Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Satko, MA
First Name & Middle Initial & Last Name & Degree
Robert Jason Yong, MD
Facility Name
OrthoNebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Olan
First Name & Middle Initial & Last Name & Degree
Joshua Urban, MD
Facility Name
Ainsworth Institute of Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoey Smith
First Name & Middle Initial & Last Name & Degree
Corey Hunter, MD
Facility Name
META Medical Research Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benu Kulkarni
First Name & Middle Initial & Last Name & Degree
Priyesh Mehta, DO
Facility Name
Kettering Health
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Mekonnen
First Name & Middle Initial & Last Name & Degree
Mark Hoeprich, MD
Facility Name
Clinical Investigations LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Orthopedic Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Good
First Name & Middle Initial & Last Name & Degree
Brian Chalkin, DO
Facility Name
HD Research
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Troy
First Name & Middle Initial & Last Name & Degree
Daneshvari Solanki, MD
Facility Name
NeuroCare Partners
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Sewall
First Name & Middle Initial & Last Name & Degree
Amie Sun-Wright, MD
Facility Name
South Texas Spinal Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Umstead
First Name & Middle Initial & Last Name & Degree
Paul Geibel, MD
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanetta Patterson
First Name & Middle Initial & Last Name & Degree
Aaron Calodney, MD
Facility Name
Virginia iSpine Physicians
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devon Withers
First Name & Middle Initial & Last Name & Degree
Michael DePalma, MD
Facility Name
Gershon Pain Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Dorrman
First Name & Middle Initial & Last Name & Degree
Steven Gershon, MD

12. IPD Sharing Statement

Learn more about this trial

Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

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