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

OhioHealth

Status

Terminated

Conditions

Intervertebral Disk Degeneration

Lumbar Degenerative Disc Disease

Spondylolisthesis

Musculoskeletal Diseases

Bone Diseases

Spinal Stenosis

Spondylolysis

Intervertebral Disk Displacement

Spinal Diseases

Spondylosis

Treatments

Biological: Demineralized Bone Matrix

Biological: NuCel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02070484

OH2-13-0034

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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