Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion
Stopped early
Conditions studied: Degenerative Disc Disease, Spondylolisthesis, Stenosis
In brief
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.
Key facts
- Study ID
- NCT02317185
- Run by
- Spine Wave
- People needed
- 2
- Starts
- 2014-12-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-04-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hospital for Special Surgery — New York, New York, United States
- Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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