Degenerative Disc DiseaseNCT02388022
A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.
An observational study of Degenerative Disc Disease, run by Globus Medical Inc.
Trial summary
The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Degenerative Disc Disease
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both male and female between the ages of 18 and 80 with objective evidence of degenerative disc disease between L2 and S1 at 1-2 contiguous levels.
Who may be able to join
- Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 resulting from degeneration of disc confirmed by history and radiographic studies.
- At least 18 years of age and maximum 80 years of age
Who cannot join
- • Presence of systemic or localized infection at the site of surgery
- More than 2 levels to be instrumented
- Previous fusion attempt at the involved level(s)
- Spondylolisthesis unable to be reduced to Grade 1
- Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- Diagnosis of a condition or on postoperative medication(s), which may interfere with bony/soft tissue healing
Show all 9Show fewer
- Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- History of substance abuse (drugs or alcohol)
- Mentally incompetent or prisoner
About this study
The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.
Read the detailed description
This is a multi center retrospective study with 200 patients. Sites will screen their patient records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent follow-up visits.
The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.
- Conditions
- Degenerative Disc Disease
- Being tested
- Degenerative Disc Disease
- 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.
Degenerative Disc DiseaseDevice
Also called CALIBER
lumbar interbody with posterior screw and rod instrumentation
| Study group | Role | What they receive |
|---|---|---|
| degenerative disc disease | Patients who have had a transforaminal lumbar interbody fusion at 1-2 contiguous levels with the CALIBER® expandable spacer and have completed at least 2 year follow-up. Receives: Device: Degenerative Disc Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic evaluation
Standing anterior-posterior, lateral, flexion and extension images
Measured: Pre-Op to 2 years post-operative
Secondary outcomes (1)
Clinical outcomes
Visual Analog Scale, Oswestry Disability Index, Neurological Exam
Measured: pre-op to 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionMar 2016
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Globus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choll Kim, MD, Principal investigator, Spine Institute of San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388022
- Sponsor's protocol ID
- RGC13-005-PL_A
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Once data collection is complete and analyzed, we will submit to journals for publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.
- ClinicalTrials.gov ID
- NCT02388022
- Acronym / sponsor ID
- RGC13-005-PL_A
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Mar 2015 (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 purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.
Detailed description
This is a multi center retrospective study with 200 patients. Sites will screen their patient records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent follow-up visits.
The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| degenerative disc disease | – | Device: Degenerative Disc DiseasePatients who have had a transforaminal lumbar interbody fusion at 1-2 contiguous levels with the CALIBER® expandable spacer and have completed at least 2 year follow-up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both male and female between the ages of 18 and 80 with objective evidence of degenerative disc disease between L2 and S1 at 1-2 contiguous levels.
Key inclusion criteria (2 listed)
- Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 resulting from degeneration of disc confirmed by history and radiographic studies.
- At least 18 years of age and maximum 80 years of age
Key exclusion criteria (9 listed)
- • Presence of systemic or localized infection at the site of surgery
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 |
|---|---|---|
| Degenerative Disc DiseaseAlso: CALIBERlumbar interbody with posterior screw and rod instrumentation | Device | degenerative disc disease |
Primary outcome
radiographic evaluation
Time frame: Pre-Op to 2 years post-operative
Standing anterior-posterior, lateral, flexion and extension images
1 secondary outcome
Clinical outcomes
Time frame: pre-op to 2 years post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: Yes. Once data collection is complete and analyzed, we will submit to journals for publication
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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.
Choll Kim, MD principal investigator
Spine Institute of San Diego
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Globus Medical Inc.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
radiographic evaluation (time frame: Pre-Op to 2 years post-operative). 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 10 Aug 2016.