Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2018 |
| Start Date: | December 2014 |
| End Date: | December 2016 |
CLINICAL EVALUATION OF GENEX® DS IN INSTRUMENTED POSTEROLATERAL FUSION
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.
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.
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
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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