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Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02317185
Recruitment Status : Terminated (For business reasons / product no longer available from Sponsor)
First Posted : December 15, 2014
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):
Spine Wave

Brief Summary:
The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cleared by the FDA for use in these procedures; however this study will allow more detailed characterization of geneX® ds performance in the long-term (1 year). By using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.

Condition or disease Intervention/treatment
Degenerative Disc Disease Spondylolisthesis Stenosis Device: genex bone graft with bone graft Other: autogenous bone graft

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Fusion [ Time Frame: 1 year ]
    Fusion will be assessed by a single, independent radiologist using study required x-rays (AP, Lateral, Flexion-Extension) and CT scans. On xray, fusion will be graded for bridging bone and lucencies. Flexion extension x-rays will also be evaluated to determine translational and angular motion. For these evaluations, fusion is defined as translational motion < 3mm and angular motion < 5º.CT assessments of fusion will include qualitative evaluation of the continuity of trabecular bone between the transverse processes, cortication at the peripheral edges of the fusion masses, and the absence of identifiable radiographic clefts. Quantitative volumetric measurements of the fusion mass will be performed by outlining the fusion area in each cross-sectional slice and summing all slices.

Secondary Outcome Measures :
  1. Complications [ Time Frame: 1 year ]
    Complications will be assessed by evaluating all reported adverse events. The analysis will be descriptive only.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The subject population will include adult (skeletally mature) men and women with spinal conditions for which instrumented posterolateral fusion (PLF) has been indicated as a course of treatment. Such spinal conditions may include symptomatic degenerative disc disease, spondylolisthesis (Grade I or II), or lumbar stenosis. The study is limited to those patients requiring instrumented PLF at one or two levels only. Subjects who are undergoing other spinal procedures during the same surgery (such as interbody fusions) are also eligible.

Inclusion Criteria:

  • Men or women 18-75 years of age
  • Have ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol
  • Have a spinal condition of the lumbar spine (L1-S1) requiring instrumented posterolateral fusion at one or two levels

Exclusion Criteria:

  • Patients undergoing instrumented fusion for trauma, tumor, psuedoarthrosis, or same- - level recurrent stenosis
  • Patients where placing graft material on both sides (posterolateral gutters) is not possible, for example in the case of a complete facetectomy
  • Patients requiring instrumented fusion in the cervical or thoracic spine
  • Extraspinal cause of back pain such as trauma, infection, instrumentation failure, or neoplasm
  • Severe degenerative bone disease
  • Hypercalcemia
  • Active local or systemic infection
  • Morbid obesity defined as BMI > 40
  • Patients who are pregnant / able to become pregnant and not following a reliable contraceptive method
  • Uncooperative patients who can't or won't follow post-operative instructions including individuals who abuse drugs or alcohol
  • Anatomy or other factors that prohibit safe surgical access to the surgical site
  • Allergy or sensitivity to any component of the treatment procedure
  • Inadequate tissue coverage over the operative site
  • Inadequate bone stock or bone quality
  • Fever or leukocytosis
  • Uncorrectable coagulopathy or hemorrhagic diathesis
  • Uncontrolled diabetes
  • Severe vascular disease or cardiopulmonary conditions that present prohibitive anesthesia risk
  • Neuromuscular disease or disorder
  • Mental illness
  • Has an active workman's compensation lawsuit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02317185

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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 20284
Sponsors and Collaborators
Spine Wave

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Responsible Party: Spine Wave Identifier: NCT02317185     History of Changes
Other Study ID Numbers: GEN-1401
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases