Degenerative Disc DiseaseNCT03162666
Patient Outcomes Using an Expandable Spacer
An observational study of Degenerative Disc Disease, run by Globus Medical Inc at 1 site in United States.
Trial summary
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- ALTERA
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 6 Nov 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that present to Rush University Medical Center
Who may be able to join
- Adult (18-70 y/o)
- Male or Female
- With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- Degenerative disc disease with up to Grade I spondylolisthesis
- Spondylolisthesis
- Failure of at least 6-months conservative treatment
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- BMI < 40
- Subject to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one
- Ability to read, understand, and sign informed consent
Who cannot join
- Infection, local to the operative site
- Signs of local inflammation
- Fever or leukocytosis
- Pregnancy
- Significant mental disorder or condition that could compromise the Subject's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
- Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach
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- Prior fusion procedure at an adjacent level
- Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
- Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
- Active local infection in or near the operative region
- Active systemic infection and/or disease
- Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
- Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
- Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs
- Suspected or documented allergy or intolerance to implant's materials
- Symptomatic cardiac disease
- Subject unwilling to cooperate with postoperative instructions.
- Any case where the implant components selected for use would be too large or too small to achieve a successful result.
- Subject having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
- Any Subject in which implant utilization would interfere with anatomical structures or expected physiological performance.
- Prior fusion at the level to be treated.
- Back VAS < 4/10
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.
Read the detailed description
The evaluation is based on the following elements.
- Safety as measured by the rate of serious operative and post-operative complications.
- Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.
- Global and segmental lumbar lordosis (LL)
Patients will be followed upto 24 months post-operative
- Conditions
- Degenerative Disc Disease
- Being tested
- ALTERA
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTERADevice
degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Radiographic Analysis
Global and Segmental Lumbar Lordosis in degrees
Measured: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Secondary outcomes (7)
Complications
Surgical or device related complications
Measured: Intra-operative, any time post-op upto 24 months
Change in Patient Reported Outcomes as a number score
Visual Analog Scale, Oswestry Disability Index, Short Form 12, PROMIS
Measured: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Peri operative clinical parameters
Estimated Blood Loss in cc
Measured: Intra-Operative
Clinical parameters in days
Length of Hospital Stay
Measured: Immediate Post-operative
Peri operative clinical parameters in mgs
Narcotic Consumption
Measured: Immediate Post-operative
Intra-Operative clinical parameters in minutes
Operative Time
Measured: Intra-Operative
Changes in Radiographic Analysis in percentage
Fusion Rates
Measured: 6weeks, 12 weeks, 6months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start28 Feb 2017
- Primary completion6 Nov 2020 (estimated)
- Study completion6 Nov 2020 (estimated)
Why it stopped: The participating party (Rush) stopped the study because of logistic issues.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Globus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kern Singh, MD, Principal investigator, Rush Univeristy Medical Center Orthopedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162666
- Sponsor's protocol ID
- RGC16-001
- Status last verified
- Sep 2020
- First submitted
- 17 May 2017
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device
- ClinicalTrials.gov ID
- NCT03162666
- Acronym / sponsor ID
- RGC16-001
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The participating party (Rush) stopped the study because of logistic issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 6 Nov 2020 (estimated)
- Study completion
- 6 Nov 2020 (estimated)
- First posted
- 22 May 2017 (actual)
- 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.
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.
Detailed description
The evaluation is based on the following elements.
- Safety as measured by the rate of serious operative and post-operative complications.
- Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.
- Global and segmental lumbar lordosis (LL)
Patients will be followed upto 24 months post-operative
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that present to Rush University Medical Center
Key inclusion criteria (9 listed)
- Adult (18-70 y/o)
- Male or Female
- With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- Failure of at least 6-months conservative treatment
- BMI < 40
Key exclusion criteria (22 listed)
- Infection, local to the operative site
- Signs of local inflammation
- Fever or leukocytosis
- Pregnancy
- Significant mental disorder or condition that could compromise the Subject's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
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 |
|---|---|---|
| ALTERAdegenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis | Device | – |
Primary outcome
Change in Radiographic Analysis
Time frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Global and Segmental Lumbar Lordosis in degrees
7 secondary outcomes
Complications
Time frame: Intra-operative, any time post-op upto 24 months
Change in Patient Reported Outcomes as a number score
Time frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Peri operative clinical parameters
Time frame: Intra-Operative
Clinical parameters in days
Time frame: Immediate Post-operative
Peri operative clinical parameters in mgs
Time frame: Immediate Post-operative
Intra-Operative clinical parameters in minutes
Time frame: Intra-Operative
Changes in Radiographic Analysis in percentage
Time frame: 6weeks, 12 weeks, 6months, 12 months, 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Kern Singh, MD principal investigator
Rush Univeristy Medical Center Orthopedic Surgeon
1 site 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, run by Globus Medical Inc at 1 site 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 9 inclusion and 22 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: withdrawn, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Change in Radiographic Analysis (time frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months). 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 23 Aug 2021.