Status:
COMPLETED
Assessment of nanOss Bioactive 3D in the Posterolateral Spine
Lead Sponsor:
Pioneer Surgical Technology, Inc.
Conditions:
Degenerative Disc Disease
Spinal Stenosis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most wi...
Detailed Description
The post market clinical investigation is designed to assess instrumented PLF using nanOss Bioactive 3D bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spina...
Eligibility Criteria
Inclusion
- At least 21 years of age and skeletally mature.
- Symptomatic spinal stenosis secondary to DDD with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1 requiring instrumented PLF surgery.
- Completed a minimum of 6 months of non-operative treatment.
- Pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (AP, Lateral, Flexion and Extension images and an MRI or CT scan).
- Is willing and able to return for post-treatment exams according to the follow-up called for in the protocol.
- Is able to review, understand and sign the informed consent document.
Exclusion
- Symptomatic at more than two levels.
- Has had previous fusion surgery at the level(s) to be treated (previous discectomy, laminotomy, laminectomy or nucleolysis at the level(s) to be treated \< 6 months ago is ok).
- Has \> 11 degrees lumbar scoliosis.
- Has \> 40 BMI.
- Has \> Grade 1 spondylolisthesis.
- Has osteoporosis (T-score of -2.5 or below), osteomalacia, Paget's disease or metabolic bone disease.
- Has a disease that significantly inhibits bone healing (e.g., diabetes type 1, renal failure, impaired calcium metabolism).
- Has a medical condition that requires or has a history of chronic steroid use (i.e., oral steroids), with the exception of inhaled/nasal corticosteroids steroids or has any medical condition that requires treatment with drugs known to interfere with bone healing.
- Has a neurological disease (e.g., Parkinson's disease), a psychosocial disorder (e.g., suicidal, diminished capacity) or has a history of substance abuse which would preclude accurate evaluation or limit the ability to comply with study requirements.
- Has either an active infection or infection at the site of surgery
- Has a systemic disease (e.g., AIDS, HIV, active hepatitis, tuberculosis)
- Has rheumatoid arthritis or other autoimmune disease.
- Has spinal tumors.
- Has an active malignancy (except non-melanoma skin cancer) or history of any invasive malignancy unless treated and in remission for at least five years.
- Has a known sensitivity or allergies to porcine collagen, PEEK, tantalum or titanium.
- Has active arachnoiditis.
- Has fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
- Is a prisoner.
- Is involved in spinal litigation at the treated level(s).
- Is participating in another clinical study that would confound Study data.
- Is pregnant or is interested in becoming pregnant while participating in the Study.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01829997
Start Date
April 1 2013
End Date
April 1 2018
Last Update
April 17 2019
Active Locations (4)
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1
Hospital for Joint Disease
New York, New York, United States, 10003
2
Hospital for Special Surgery
New York, New York, United States, 10021
3
MUSC Neurosurgery & Spine Services
Charleston, South Carolina, United States, 29425
4
Milwaukee Spinal Specialists
Glendale, Wisconsin, United States, 53212