Study of Nucel for One and Two Level Lumbar Interbody Fusion

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02808234
• Other study ID #: Nucel-2015-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolisthesis
• Spondylosis

Intervention

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

Locations

Country	Name	City	State
United States	Carolina Neurosurgery & Spine	Charlotte	North Carolina
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Florida Orthopaedic Insitute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurologic Exam	Physician conducted neurological exam	2 years
Other	Visual Analogue Scale	Patient health outcome survey	2 years
Other	Oswestry Low Back Pain Disability Index	Patient health outcome survey	2 years
Other	SF-12 health survey	Patient health outcome survey	2 years
Primary	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