Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02070484
• Date of registration: 21/02/2014
• Prospective Registration: No
• Primary sponsor: OhioHealth
• Public title: Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
• Scientific title: Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
• Date of first enrolment: February 2014
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02070484
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Joseph Shehadi, MD
• Affiliation: OhioHealth

Key inclusion & exclusion criteria

Inclusion Criteria:

- Between the ages of 18 and 75 years

- Symptomatic, single-level degenerative lumbar disc disease, spondylosis or
spondylolisthesis

- Failed conservative treatments

- Low risk for non-union

- Must be candidates for single-level, posteriolateral lumbar spine fusion

- Must be able and willing to give Informed Consent

- English-speaking

Exclusion Criteria:

- Smoker (any smoking =3 months prior to consent); (Patel et al. 2013)

- Patients with poorly controlled diabetes mellitus (HgbA1c > 7%)

- Documented osteoporosis

- Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine
level, to the level being operated on

- Back pain due to infection, tumour, or metabolic bone disease

- Terminal disease, such as HIV infection, neoplasm

- Autoimmune disease, such as rheumatoid arthritis

- Morbid obesity (body mass index (BMI) of 35 kg/m2)

- Major psychiatric illness in the last year

- History of alcohol or drug abuse in the last year

- Pregnant women



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Musculoskeletal Diseases

Spinal Diseases

Bone Diseases

Intervertebral Disk Displacement

Spinal Stenosis

Spondylolysis

Lumbar Degenerative Disc Disease

Intervertebral Disk Degeneration

Spondylolisthesis

Spondylosis

Intervention(s)

Biological: NuCel

Biological: Demineralized Bone Matrix

Primary Outcome(s)

Oswestry Disability Index [Time Frame: 6 months]

Oswestry Disability Index [Time Frame: Baseline]

Oswestry Disability Index [Time Frame: 1 month]

Oswestry Disability Index [Time Frame: 12 months]

Oswestry Disability Index [Time Frame: 2 months]

Oswestry Disability Index [Time Frame: 3 months]

Secondary Outcome(s)

Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion [Time Frame: 6 and 12 months]

Secondary ID(s)

OH2-13-0034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NuTech Medical, Inc

Results

• Results available: Yes
• Date Posted: 27/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02070484