Clinical trial NCT02808234: Study of Nucel for One and Two Level Lumbar Interbody Fusion
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disc Disease
Spondylolisthesis
Spondylosis
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Fusion rate using non-contrast CT of the lumbar spine
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Neurologic Exam
timeFrame: 2 years
measure: Visual Analogue Scale
timeFrame: 2 years
measure: Oswestry Low Back Pain Disability Index
timeFrame: 2 years
measure: SF-12 health survey
timeFrame: 2 years
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Insitute
state: Florida
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine
state: North Carolina
Study officials:
affiliation: Spine Institute of Louisiana
name: Pierce Nunley, MD
role: PRINCIPAL_INVESTIGATOR
References: