Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease; Spondylolisthesis; Stenosis
• Intervention / Treatment: Device: genex bone graft with bone graft; Other: autogenous bone graft

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
  • North Carolina
    • Charlotte, North Carolina, United States, 20284
      • Carolina Neurosurgery and Spine Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications will be assessed by evaluating all reported adverse events. The analysis will be descriptive only.	1 year

Collaborators and Investigators

• Sponsor: Spine Wave

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (ESTIMATE): December 15, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: GEN-1401