Degenerative Disc DiseaseFLXFitNCT02805985
Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
A study testing FLXfit™ TLIF Interbody Fusion Device in people with Degenerative Disc Disease and Spondylolisthesis, run by Expanding Orthopedics Ltd. at 1 site in United States.
Trial summary
This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- What is being tested?
- FLXfit™ TLIF Interbody Fusion Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jun 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
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
Show all 9Show fewer
- BMI < 40
- Patient 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 patient'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
Show all 22Show fewer
- 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
- Patient 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.
- Patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
- Any patient 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; Department of Orthopedic Surgery
Chicago, Illinois, 60612
Kern Singh, MD, 312-432-2373, kern.singh@rushortho.com
About this study
This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.
Read the detailed description
As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.
The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in height. This enables larger footprint support as well as restoration of disc height and lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of insertion. The open architecture of the device allows it to be packed with autogenous bone graft.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Being tested
- FLXfit™ TLIF Interbody Fusion Device
- Keywords
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLXfit™ TLIF Interbody Fusion DeviceDevice
The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.
| Study group | Role | What they receive |
|---|---|---|
| FLXfit™ TLIF Interbody Fusion Device | Experimental | The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. Receives: Device: FLXfit™ TLIF Interbody Fusion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Adverse Events
All adverse events will be assessed by incidence and time to resolution of postoperative device-related complications and serious adverse events/incidence and time to reoperation/incidence and time to revision. All perioperative adverse events will be noted. Information will be obtained from the operative note regarding blood loos, length of surgery, procedural details and complications. Postoperative events including nausea, vomiting, wound complications, thromboembolic events will be assessed.
Measured: Up to 24 months
Secondary outcomes (9)
Disability
Obtaining improvement in Oswestry Disability Index (ODI) disease-specific questionnaire up to 24 months following the procedure, as compared to patient's baseline. Mean change in score of the ODI from baseline to 24 months postoperatively
Measured: 24 months
Change in Disability
Obtaining improvement in Oswestry Disability Index (ODI) disease-specific questionnaire up to 24 months following the procedure, as compared to patient's baseline. Mean change in score of the ODI from baseline to 24 months postoperatively
Measured: Up to 24 months
Pain
Obtaining improvement in Visual Analogue Scale (VAS) Back and Leg pain scores up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the VAS from baseline to 24 months postoperatively
Measured: 24 months
Change in Pain
Obtaining improvement in Visual Analogue Scale (VAS) Back and Leg pain scores up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the VAS from baseline to 24 months postoperatively
Measured: Up to 24 months
Health-Related Quality of Life Questionnaire
Obtaining improvement in Short Form-12 health survey up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the SF-12 from baseline to 24 months postoperatively
Measured: 24 months
Change in Health-Related Quality of Life Questionnaire
Obtaining improvement in Short Form-12 health survey up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the SF-12 from baseline to 24 months postoperatively
Measured: Up to 24 months
Arthrodesis (Fusion)
CT based fusion assessment at 6 months, 12 months, and 24 months
Measured: 6 months, 12 months, 24 months
Radiographic Analysis (Global Lumbar Lordosis)
Immediate Postoperative, and at the 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits assessing global lumbar lordosis (LL) at the level treated with the FLXfit device.
Measured: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits
Radiographic Analysis (Segmental Lumbar Lordosis)
Immediate Postoperative, and at the 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits assessing segmental lumbar lordosis (LL) at the level treated with the FLXfit device.
Measured: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Expanding Orthopedics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Responsible party
- Sponsor
- Investigators
- Dustin H Massel, BS, Study director, Rush University Medical CenterBenjamin C Mayo, BA, Study director, Rush University Medical CenterFady Hijji, BS, Study director, Rush University Medical CenterKern Singh, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805985
- Sponsor's protocol ID
- FLXFit
- Acronym
- FLXFit
- Status last verified
- Jan 2017
- First submitted
- 25 May 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
- ClinicalTrials.gov ID
- NCT02805985
- Acronym / sponsor ID
- FLXFit / FLXFit
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Keywords
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Expanding Orthopedics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 20 Jun 2016 (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.
This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.
Detailed description
As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.
The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in height. This enables larger footprint support as well as restoration of disc height and lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of insertion. The open architecture of the device allows it to be packed with autogenous bone graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLXfit™ TLIF Interbody Fusion Device | Experimental | Device: FLXfit™ TLIF Interbody Fusion DeviceThe FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 patient'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 |
|---|---|---|
| FLXfit™ TLIF Interbody Fusion DeviceThe FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. | Device | FLXfit™ TLIF Interbody Fusion Device |
Primary outcome
Safety/Adverse Events
Time frame: Up to 24 months
All adverse events will be assessed by incidence and time to resolution of postoperative device-related complications and serious adverse events/incidence and time to reoperation/incidence and time to revision. All perioperative adverse events will be noted. Information will be obtained from the operative note regarding blood loos, length of surgery, procedural details and complications. Postoperative events including nausea, vomiting, wound complications, thromboembolic events will be assessed.
9 secondary outcomes
Disability
Time frame: 24 months
Change in Disability
Time frame: Up to 24 months
Pain
Time frame: 24 months
Change in Pain
Time frame: Up to 24 months
Health-Related Quality of Life Questionnaire
Time frame: 24 months
Change in Health-Related Quality of Life Questionnaire
Time frame: Up to 24 months
Arthrodesis (Fusion)
Time frame: 6 months, 12 months, 24 months
Radiographic Analysis (Global Lumbar Lordosis)
Time frame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits
Radiographic Analysis (Segmental Lumbar Lordosis)
Time frame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Individual participant dataSharing planned: Yes
Related trials for Degenerative Disc Disease
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
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.
Dustin H Massel, BS study director
Rush University Medical Center
Benjamin C Mayo, BA study director
Rush University Medical Center
Fady Hijji, BS study director
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLXfit™ TLIF Interbody Fusion Device in people with Degenerative Disc Disease and Spondylolisthesis, run by Expanding Orthopedics Ltd. 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: status not confirmed, as of the sponsor's last update on 25 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kern Singh, MD (312-432-2373, kern.singh@rushortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Adverse Events (time frame: Up to 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 25 Jan 2017.