NanOss Bioactive With Autograft and Bone Marrow Aspirate in the Posterolateral Spine

A Prospective, Nonrandomized Study to Assess Lumbar Fusion With Instrumented Posterolateral Gutter Fusions Using NanOss Bioactive

The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler

Study Overview

• Status: Withdrawn
• Conditions: Lumbar Spinal Stenosis Secondary to Other Disease
• Intervention / Treatment: Device: Autograft; Device: nanOSS

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is at least 21 years of age and skeletally mature.
2. Must have cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one level in the cervical spine between C3 to T1.
3. Must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.
4. Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (Anteroposterior/Lateral/Flexion/Extension X-rays & a recent MRI).
5. Is willing and able to comply with all clinical investigation visits and procedures including screening treatment procedures, post-operative management, the follow-up schedule and completion of forms or questionnaires.
6. Is able to understand and sign the patient information sheet/informed consent form.

Exclusion Criteria:

1. Requires fusion at more than one level.
2. Has had prior fusion at the level to be treated.
3. Has a metabolic or systemic bone disorder.
4. Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease).
5. Has a systemic or local infection (active or latent).
6. Has acute or chronic infections in the surgical area (i.e., soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis).
7. Chronic use of steroids, other than episodic use or inhaled corticosteroids.
8. Has any significant general illness (i.e., HIV, active metastatic cancer of any type, uncontrolled diabetes Type I, dialysis dependent renal failure, symptomatic liver disease).
9. Has a mental or physical condition that would limit the ability to comply with study requirements or would preclude accurate evaluation.
10. Is immunocompromised or being treated with immunosuppressive agents (including chemotherapy or radiation treatment).
11. Has documented allergies to hydroxyapatite or porcine collagen, PEEK, titanium, titanium alloy or tantalum.
12. Is currently pregnant, or interested in becoming pregnant during the clinical investigation follow-up.
13. Is a smoker.
14. Is non-English speaking.
15. Requires the use of a bone-growth stimulator.
16. Is a prisoner.
17. Is currently involved in another drug or device clinical investigation that may confound the clinical trial investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autograft bone	Device: Autograft
Experimental: nanOss with bone marrow aspirate	Device: nanOSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fusion at 12 months postoperatively.	12 months

Collaborators and Investigators

• Sponsor: Pioneer Surgical Technology, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: fusion; Lumbar
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Disease; Spinal Stenosis
• Other Study ID Numbers: 2010-02b

Plan for Individual participant data (IPD)

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