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

Not Applicable

Terminated

• Conditions: Spondylolisthesis; Intervertebral Disk Displacement; Spinal Diseases; Bone Diseases; Spondylolysis; Spinal Stenosis; Lumbar Degenerative Disc Disease; Spondylosis; Intervertebral Disk Degeneration; Musculoskeletal Diseases
• Interventions: Biological: NuCel; Biological: Demineralized Bone Matrix

• Registration Number: NCT02070484
• Lead Sponsor: OhioHealth

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Primary Completion: 2017-03-24
• Study Completion: 2017-03-24
• Results First Submitted: 2018-04-13
• Results First Submitted QC: 2018-07-27
• Status Verified: 2018-08
• Results First Posted: 2018-08-27
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NuCel	NuCel	Stemcell allograft
Demineralized Bone Matrix (DBM)	Demineralized Bone Matrix	Demineralized Bone Matrix (DBM) bone graft substitute

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	6 months	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

Secondary Outcome Measures

Name	Time	Method
Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion	6 and 12 months	CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.

Trial Locations

Locations (2)

Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

Grant Medical Center; 🇺🇸 Columbus, Ohio, United States