Study of Nucel for One and Two Level Lumbar Interbody Fusion

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Disc Disease; Spondylosis; Spondylolisthesis
• Intervention / Treatment: Procedure: One or two level lumbar interbody fusion surgery; Other: Nucel

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
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33609
      • Florida Orthopaedic Insitute
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina NeuroSurgery & Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion rate using non-contrast CT of the lumbar spine	Fusion will be assessed 2 years by independent radiologist using alpha-numeric grading scale to quantify bone growth and supplemental fixation quality	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic Exam	Physician conducted neurological exam	2 years
Visual Analogue Scale	Patient health outcome survey	2 years
Oswestry Low Back Pain Disability Index	Patient health outcome survey	2 years
SF-12 health survey	Patient health outcome survey	2 years

Collaborators and Investigators

• Sponsor: Organogenesis
• Investigators: Principal Investigator: Pierce Nunley, MD, Spine Institute of Louisiana

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Intervertebral Disc Degeneration; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: Nucel-2015-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO