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

NCT02005341 | Withdrawn

• 1 other identifier: 2010-02b
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lumbar Spinal Stenosis Secondary to Other Disease

Keywords

Lumbar; fusion

Outcome Measures

Primary Outcomes (1)

• Fusion at 12 months postoperatively.

  12 months

Study Arms (2)

Autograft bone

ACTIVE COMPARATOR

Device: Autograft

nanOss with bone marrow aspirate

EXPERIMENTAL

Device: nanOSS

Interventions

nanOSS DEVICE

nanOss with bone marrow aspirate

Autograft DEVICE

Autograft bone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 21 years of age and skeletally mature.
• 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.
• 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.
• Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (Anteroposterior/Lateral/Flexion/Extension X-rays \& a recent MRI).
• 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.
• Is able to understand and sign the patient information sheet/informed consent form.

You may not qualify if:

• Requires fusion at more than one level.
• Has had prior fusion at the level to be treated.
• Has a metabolic or systemic bone disorder.
• Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease).
• Has a systemic or local infection (active or latent).
• Has acute or chronic infections in the surgical area (i.e., soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis).
• Chronic use of steroids, other than episodic use or inhaled corticosteroids.
• 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).
• Has a mental or physical condition that would limit the ability to comply with study requirements or would preclude accurate evaluation.
• Is immunocompromised or being treated with immunosuppressive agents (including chemotherapy or radiation treatment).
• Has documented allergies to hydroxyapatite or porcine collagen, PEEK, titanium, titanium alloy or tantalum.
• Is currently pregnant, or interested in becoming pregnant during the clinical investigation follow-up.
• Is a smoker.
• Is non-English speaking.
• Requires the use of a bone-growth stimulator.

Sponsors & Collaborators

• Pioneer Surgical Technology, Inc.: lead

MeSH Terms

Interventions

Transplantation, Autologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share