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Trial record 3 of 5 for:    nucel

Study of Nucel for One and Two Level Lumbar Interbody Fusion

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ClinicalTrials.gov Identifier: NCT02808234
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
NuTech Medical, Inc

Brief Summary:
The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis Spondylosis Procedure: One or two level lumbar interbody fusion surgery Other: Nucel Not Applicable

Detailed Description:
Two hundred non-randomized subjects will participate in the study at up to ten clinical sites in the United States. Participants will be between 18 and 75 years of age. All subjects will have been established with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon. The diseases included in the study are spondylosis, degenerative disc disease and spondylolisthesis. All subjects who meet the inclusion criteria and do not meet the exclusion criteria and who elect to participate and sign the informed consent will be included in the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Prospective, Multi-center Study of Nucel® in Patients Receiving Interbody Fusion for One and Two Level Degenerative Disease of the Lumbar Spine
Study Start Date : December 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Nucel treatment group
One or two level lumbar interbody fusion surgery with Nucel
Procedure: One or two level lumbar interbody fusion surgery
One or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid.

Other: Nucel
Allograft derived from human amnion and amniotic fluid




Primary Outcome Measures :
  1. Fusion rate using non-contrast CT of the lumbar spine [ Time Frame: 2 years ]
    Fusion will be assessed 2 years by independent radiologist using alpha-numeric grading scale to quantify bone growth and supplemental fixation quality


Other Outcome Measures:
  1. Neurologic Exam [ Time Frame: 2 years ]
    Physician conducted neurological exam

  2. Visual Analogue Scale [ Time Frame: 2 years ]
    Patient health outcome survey

  3. Oswestry Low Back Pain Disability Index [ Time Frame: 2 years ]
    Patient health outcome survey

  4. SF-12 health survey [ Time Frame: 2 years ]
    Patient health outcome survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be between 18 and 75 years of age
  2. Have clinical and/or radiological evidence of stenosis, spondylolisthesis, spondylosis or degenerative disc disease, or at either one or two levels of lumbar spine.
  3. In the opinion of the treating surgeon, must already be a qualified candidate for interbody lumbar fusion surgery with supplemental fixation.
  4. Be likely to return for regular follow-ups until the end of the study period.
  5. Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria:

  1. Previous lumbar spine fusion surgery at operative level.
  2. Back pain due to acute trauma.
  3. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
  4. No chronic steroid or chronic prescription NSAID use within three (3) months prior to surgery.
  5. Any active malignancy, infectious process, or documented chronic autoimmune disease.
  6. Any other concurrent medical disease or treatment that might impair normal healing process.
  7. Recent history (within past 6 months) of any chemical or alcohol dependence.
  8. Morbid obesity (BMI > 40).
  9. Currently a prisoner.
  10. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
  11. Pregnancy at the time of enrollment or planned pregnancy, which would interfere with follow-up imaging.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808234


Contacts
Contact: Kelly Frank, MS 512-751-7747 kfrank@louisianaspine.org
Contact: Marcus Stone, PhD 318-629-5585 mstone@louisianaspine.org

Locations
United States, Florida
Florida Orthopaedic Insitute Recruiting
Tampa, Florida, United States, 33609
Contact: Debbi Warren, RN, CCRC    813-978-9700 ext 6766    dwarren@foreonline.org   
Principal Investigator: Steven Tresser, MD         
United States, Louisiana
Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Kelly Frank, MS    512-751-7747    kfrank@louisianaspine.org   
Contact: Marcus Stone, PhD    318-629-5585    mstone@louisianaspine.org   
Principal Investigator: Pierce Nunley, MD         
United States, North Carolina
Carolina Neurosurgery & Spine Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: Peggy Boltes    704-376-1605    Peggy.Boltes@CNSA.com   
Principal Investigator: Dr. Dom Coric, MD         
Sponsors and Collaborators
NuTech Medical, Inc
Investigators
Principal Investigator: Pierce Nunley, MD Spine Institute of Louisiana

Responsible Party: NuTech Medical, Inc
ClinicalTrials.gov Identifier: NCT02808234     History of Changes
Other Study ID Numbers: Nucel-2015-03
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spondylolisthesis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis