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

NCT ID: NCT02005341

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-09-30

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

Study Design

• Primary Study Purpose: TREATMENT

Study Groups

Autograft bone

Group Type: ACTIVE_COMPARATOR

Autograft

Intervention Type: DEVICE

nanOss with bone marrow aspirate

Group Type: EXPERIMENTAL

nanOSS

Intervention Type: DEVICE

Interventions

nanOSS

Intervention Type: DEVICE

Autograft

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pioneer Surgical Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2010-02b

Identifier Type: -

Identifier Source: org_study_id