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

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ClinicalTrials.gov Identifier: NCT02005341
Recruitment Status : Withdrawn (A change in research priorities after a merger)
First Posted : December 9, 2013
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.

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

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Secondary to Other Disease Device: nanOSS Device: Autograft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: A Prospective, Nonrandomized Study to Assess Lumbar Fusion With Instrumented Posterolateral Gutter Fusions Using NanOss Bioactive
Study Start Date : October 2011
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Arm Intervention/treatment
Active Comparator: Autograft bone Device: Autograft
Experimental: nanOss with bone marrow aspirate Device: nanOSS



Primary Outcome Measures :
  1. Fusion at 12 months postoperatively. [ Time Frame: 12 months ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT02005341     History of Changes
Other Study ID Numbers: 2010-02b
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pioneer Surgical Technology, Inc.:
Lumbar
fusion

Additional relevant MeSH terms:
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Spinal Stenosis
Disease
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes