Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine

NCT01968993 | Completed

• 1 other identifier: 2010-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the treated level(s). It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis

Keywords

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Fusion

  Based on x-ray and CT scan. Defined as bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion. X-rays obtained at 6 months and 12 months. CT obtained at 12 months.

  12 months

Secondary Outcomes (6)

• Improvement in Oswestry Disability Index score

  Preoperatively, 6 months, 12 months

• Improvement in VAS pain scores

  Preoperatively, 6 months, 12 months

• Improvement in Short Form-36 scores (SF-36)

  Preoperatively, 6 months, 12 months

• Decrease in medication usage

  Preoperatively, 6 months, 12 months

• Work status

  Preoperatively, 6 months, 12 months

Other Outcomes (1)

• Complications, adverse events and neurological status

  6 months, 12 months

Study Arms (1)

nanOss Bioactive - posterolateral gutter

EXPERIMENTAL

Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter.

Device: nanOss Bioactive - posterolateral gutter

Interventions

nanOss Bioactive - posterolateral gutter DEVICE

Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter.

nanOss Bioactive - posterolateral gutter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is at least 18 years of age and skeletally mature.
• must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1 requiring a fusion.
• must have completed a minimum of three months of unsuccessful conservative, non-operative care.
• must have discogenic back pain with or without leg pain.
• DDD must be confirmed by MRI or CT scans followed by discography (if necessary).
• must score at least 40% on the Oswestry Disability Index.
• must score at least a 4 on a 10 cm Visual Analog Scale for back pain.
• must be able to comply with the protocol's follow-up schedule.
• must understand and sign the informed consent document.

You may not qualify if:

• symptomatic at more than 2 levels.
• previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the operative (involved) level \> 6 months is permitted).
• more than 50% spondylolisthesis.
• lumbar scoliosis greater than 11 degrees.
• osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease.
• spinal tumors.
• active arachnoiditis.
• fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
• impaired calcium metabolism.
• active infection or surgical site infection.
• rheumatoid arthritis or other autoimmune disease
• chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
• systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
• morbid obesity defined as body mass index (BMI)\>40 or a weight more than 100lbs over ideal body weight.
• smokers unless the patient agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.

Sponsors & Collaborators

• Pioneer Surgical Technology, Inc.: lead

Study Sites (3)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Columbia Orthopedic Group

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Robert Eastlack, MD

  Scripps Green Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Highland, MD

  Columbia Orthopedic Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 24, 2013
• Study Start: January 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)