clinical outcome and fusion results using the verteloc® facet fixation device

Conditions: Spinal Stenosis

Summary: the purpose of this clinical study is to evaluate fusion of the facet joints in a prospective cohort of patients utilizing the verteloc facet fixation device in patients receiving lumbar laminectomy (l1-s1), without ancillary stabilization devices such as pedicle and transfacet screws.

study design: non-randomized, prospective, single arm clinical trial patient population and sample size: patients (n=25) from up to 2 clinical site, who have been medically evaluated, found appropriate for, and have agreed to treatment by lumbar decompressive laminectomy and facet fixation, including unilateral and/or bilateral posterolateral fusion according to accepted medical standards. objectives: the primary objective of this study is to: 1. evaluate the fusion status of facet joints following laminectomy and facet fixation using the verteloc system in combination with unilateral and/or bilateral posterolateral fusion. 2. subject success / clinical outcome: evaluate the reduction in baseline vas back pain score at 2-3 weeks, 3 months, and 12 months. the secondary objectives of this study are to: 1. explore the effect of preoperative bone density on facet fusion status; 2. assess the ease of use of the verteloc system; 3. record operative time using the verteloc system; 4. monitor the occurrence of adverse events related or possibly related to the use of the verteloc system; 5. monitor the occurrence of subsequent surgical intervention at the target level(s). 6. subject success/clinical outcome (assess additional improvement criteria) 7. evaluate fusion rate in relations to dexa value inclusion criteria: candidates must meet all of the following: 1. have provided consent for research by signing the institutional review board approved informed consent; 2. have given appropriate operative consent for a decompressive lumbar (l1-s1) laminectomy procedure as standard of care; 3. are skeletally mature, and are at least 18 years of age; 4. if female, are not pregnant; 5. agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation. exclusion criteria: 1. previous surgery at the target or adjacent vertebral levels; 2. more than two intervertebral levels to be treated by the laminectomy procedure; 3. found to be inappropriate candidates for facet fixation using the verteloc system; 4. require additional and/or other surgical technique and/or approach to the laminectomy at the index level(s), which may in the opinion of the primary investigator confound measurement of outcome variables; 5. has a medical disorder or is receiving medications that would be expected to interfere with osteogeneses, 6. active malignancy or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years of surgery; 7. active local or systemic infection or history of local or systemic infection, immune-deficiency, uncontrolled medical conditions, which in the opinion of the investigator may increase patient risk or confound fusion results; 8. bmi \>40% ; 9. history of tobacco smoking within the past 6 months; 10. has a history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or has a personality disorder, poor motivation, emotional or intellectual issues that would likely make the patient unreliable for participation in the study; 11. are participating in any other clinical trial. study duration : 12 months study outcomes: the primary study outcomes of this study are: 1. fusion grade at 12 month follow-up using ct scans with a grading system based on: 1. complete fusion; 2. partial fusion; 3. no fusion; 2. subject success / clinical outcome: evaluate the reduction in baseline vas back pain score at: 1. 2-3 weeks 2. 3 months 3. 12 months. the secondary outcomes of this study are: 1. statistical correlation of dexa scan bone mass density score to ct and radiographic fusion status; 2. surgeon opinion of "ease of use" utilizing the verteloc system (0-10); 3. operative time (minutes) from surgical access to completion of device placement 4. occurrence and prevalence of adverse events related or possibly related to the use of the verteloc system; 5. occurrence of subsequent surgical intervention at the target level(s). study assessments * intraoperative: post-placement radiograph; * 12 months: a/p and lateral flexion and extension lumbar radiograph and lumbar ct scan. statistical analysis • student t-tests

Eligibility criteria:
inclusion criteria: 1. have provided consent for research by signing the institutional review board approved informed consent; 2. have given appropriate operative consent for a decompressive lumbar (l1-s1) laminectomy procedure as standard of care; 3. are skeletally mature, and are at least 18 years of age; 4. if female, are not pregnant; 5. agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation. exclusion criteria: 1. previous surgery at the target or adjacent vertebral levels; 2. more than two intervertebral levels to be treated by the laminectomy procedure; 3. found to be inappropriate candidates for facet fixation using the verteloc system; 4. require additional and/or other surgical technique and/or approach to the laminectomy at the index level(s), which may in the opinion of the primary investigator confound measurement of outcome variables; 5. has a medical disorder or is receiving medications that would be expected to interfere with osteogeneses, 6. active malignancy or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years of surgery; 7. active local or systemic infection or history of local or systemic infection, immune-deficiency, uncontrolled medical conditions, which in the opinion of the investigator may increase patient risk or confound fusion results; 8. bmi \>40% ; 9. history of tobacco smoking within the past 6 months; 10. has a history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or has a personality disorder, poor motivation, emotional or intellectual issues that would likely make the patient unreliable for participation in the study; 11. are participating in any other clinical trial.