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

Primary Purpose

Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nanOss Bioactive - posterolateral gutter
Sponsored by
Pioneer Surgical Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative Disc Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Green Hospital
  • University of California San Francisco
  • Columbia Orthopedic Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nanOss Bioactive - posterolateral gutter

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improvement in Oswestry Disability Index score
As compared to baseline levels
Improvement in VAS pain scores
As compared to baseline levels.
Improvement in Short Form-36 scores (SF-36)
As compared to baseline levels.
Decrease in medication usage
As compared to baseline levels.
Work status
As compared to baseline levels.
Patient satisfaction
As compared to baseline levels.

Full Information

First Posted
October 21, 2013
Last Updated
November 7, 2016
Sponsor
Pioneer Surgical Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01968993
Brief Title
Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pioneer Surgical Technology, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
Keywords
Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nanOss Bioactive - posterolateral gutter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
nanOss Bioactive - posterolateral gutter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fusion
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement in Oswestry Disability Index score
Description
As compared to baseline levels
Time Frame
Preoperatively, 6 months, 12 months
Title
Improvement in VAS pain scores
Description
As compared to baseline levels.
Time Frame
Preoperatively, 6 months, 12 months
Title
Improvement in Short Form-36 scores (SF-36)
Description
As compared to baseline levels.
Time Frame
Preoperatively, 6 months, 12 months
Title
Decrease in medication usage
Description
As compared to baseline levels.
Time Frame
Preoperatively, 6 months, 12 months
Title
Work status
Description
As compared to baseline levels.
Time Frame
Preoperatively, 6 months, 12 months
Title
Patient satisfaction
Description
As compared to baseline levels.
Time Frame
Preoperatively, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Complications, adverse events and neurological status
Description
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.
Time Frame
6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Eastlack, MD
Organizational Affiliation
Scripps Green Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Highland, MD
Organizational Affiliation
Columbia Orthopedic Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Columbia Orthopedic Group
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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