Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

NCT02317185 | Terminated

• 1 other identifier: GEN-1401
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications

  1 year

Interventions

genex bone graft with bone graft DEVICE

autogenous bone graft OTHER

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Spine Wave: lead

Study Sites (2)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 20284, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Constriction, Pathologic

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 15, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

US (2)