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

A Prospective, Nonrandomized Study to Assess Lumbar Fusion Using Interbody Cages With Autograft in Conjunction With Instrumented Posterolateral Gutter Fusions Using nanOss Bioactive and Autograft Bone.

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis
• Intervention / Treatment: Device: nanOss Bioactive - posterolateral gutter

Detailed Description

The post market clinical investigation is designed to assess instrumented posterolateral fusion (PLF) using nanOss Bioactive bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1.

Preoperatively, the participant will provide his/her medical history and complete self assessment forms. The investigator will perform a clinical evaluation and x-rays will be performed if recent x-rays are not available. Participants will undergo instrumented PLF with an interbody fusion device (with autograft or allograft) using nanOss Bioactive in combination with autograft bone and bone marrow aspirate in one posterolateral gutter and autograft alone in the opposite posterolateral gutter.

Following surgery, operative and discharge information will be collected and a clinical evaluation will be performed prior to discharge. Participants will be evaluated 6 and 12 months postoperatively. One investigational site will participate in long-term followup of 24 months. Each participant will complete x-rays and self assessment documents. A CT scan performed at the 12 month postoperative visit will be evaluated by an independent radiologist to assess fusion results. Complication data will be recorded throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopedic Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse.
• active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
• documented allergies to porcine collagen or titanium
• pregnancy, or interested in becoming pregnant in the next four years.
• participation in another investigational study within 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nanOss Bioactive - posterolateral gutter; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Oswestry Disability Index score	As compared to baseline levels	Preoperatively, 6 months, 12 months
Improvement in VAS pain scores	As compared to baseline levels.	Preoperatively, 6 months, 12 months
Improvement in Short Form-36 scores (SF-36)	As compared to baseline levels.	Preoperatively, 6 months, 12 months
Decrease in medication usage	As compared to baseline levels.	Preoperatively, 6 months, 12 months
Work status	As compared to baseline levels.	Preoperatively, 6 months, 12 months
Patient satisfaction	As compared to baseline levels.	Preoperatively, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications, adverse events and neurological status	Incidence of reoperations, revisions, supplemental fixations, neurological failures, unexpected adverse events or complications will be calculated. Percentage of patients in each category will be reported and exact 95% confidence intervals will be calculated using the inverse beta distribution.	6 months, 12 months

Collaborators and Investigators

• Sponsor: Pioneer Surgical Technology, Inc.
• Investigators: Principal Investigator: Robert Eastlack, MD, Scripps Green Hospital; Principal Investigator: Thomas Highland, MD, Columbia Orthopedic Group

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 7, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Degenerative Disc Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 2010-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No