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

Musculoskeletal Diseases Clinical Trial

Official title:

Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02070484
• Other study ID #: OH2-13-0034
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: March 24, 2017

Study information

• Verified date: August 2018
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 24, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Intervertebral Disk Degeneration
• Intervertebral Disk Displacement
• Lumbar Degenerative Disc Disease
• Musculoskeletal Diseases
• Spinal Diseases
• Spinal Stenosis
• Spondylolisthesis
• Spondylolysis
• Spondylosis

Intervention

Biological:
• NuCel

• Demineralized Bone Matrix

Locations

Country	Name	City	State
United States	Grant Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	NuTech Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	12 months
Primary	Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	Baseline
Primary	Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	1 month
Primary	Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	2 months
Primary	Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	3 months
Primary	Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	6 months
Secondary	Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion	CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.	6 and 12 months