Degenerative Disc DiseaseNCT02317185
Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Spine Wave at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- What is being tested?
- genex bone graft with bone graft and autogenous bone graft
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 20284
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: 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.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- Being tested
- genex bone graft with bone graft, autogenous bone graft
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genex bone graft with bone graftDevice
autogenous bone graftOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Complications
Complications will be assessed by evaluating all reported adverse events. The analysis will be descriptive only.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: For business reasons / product no longer available from Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Wave
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317185
- Sponsor's protocol ID
- GEN-1401
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2014
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EVALUATION OF GENEX® DS IN INSTRUMENTED POSTEROLATERAL FUSION
- ClinicalTrials.gov ID
- NCT02317185
- Acronym / sponsor ID
- GEN-1401
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: For business reasons / product no longer available from Sponsor
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Spine WaveIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genex bone graft with bone graft | Device | – |
| autogenous bone graft | Other | – |
Primary outcome
Fusion
Time frame: 1 year
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 secondary outcome
Complications
Time frame: 1 year
Results and safety
The study was stopped early (reason given: For business reasons / product no longer available from Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Spine Wave at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: For business reasons / product no longer available from Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.