Degenerative Disc DiseaseAPROPOSNCT02704689

AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

A study testing AccuLIF expandable TLIF cage in people with Degenerative Disc Disease and Spondylolisthesis, Grade 1, run by VB Spine, LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
What is being tested?: AccuLIF expandable TLIF cage
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2016to 19 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subject is skeletally mature and between 18 and 70 years of age.
DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
Subject agrees to comply with visit schedule and completing study questionnaires.

Who cannot join

Significant instability of the spine.
Requires TLIF at more than 2 levels between L2 and S1.
Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
Younger than 18 years of age, or older than 70 years of age.
BMI of 40 or greater.
History of metabolic bone disease

Show all 26Show fewer

Osteoporosis
Diabetes mellitus requiring daily insulin management.
Subject has any of the following:
Progressive neuromuscular disease; OR
Autoimmune disease; OR
Active malignancy within the last 15 years; OR
Active hepatitis; OR
AIDS, ARC, or is HIV positive; OR
Syringomyelia at any spinal level; OR
Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.
Allergy to implant materials (titanium, titanium alloy).
Active systemic infection or infection localized to the site of implantation.
Primary or metastatic tumors involving the spine.
Open wounds or inadequate issue tissue coverage over the operative site.
History of significant mental illness or mental incapacity.
Pregnancy or intent to become pregnant.
Participating in another investigational study for a similar purpose.
Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements.
Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years.
Workers compensation.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri Health Care
Columbia, Missouri, 65212

Other trials in United States

About this study

Official title: A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine

Read the detailed description

Study evaluations will be evaluated pre-operatively and at 6-weeks, 3-months, 6-months, 12-months and 24-months post-operatively to assess clinical outcomes, patient reported outcomes and radiographic status.

Conditions: Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
Being tested: AccuLIF expandable TLIF cage
Medical subject headings: Intervertebral Disc Degeneration, Spondylolisthesis, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AccuLIF expandable TLIF cageDevice
AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.

Study groups in NCT02704689
Study group	Role	What they receive
AccuLIF	Experimental	Not described Receives: Device: AccuLIF expandable TLIF cage

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.
Measured: 24 months
Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.
Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.
Measured: 24 months

Secondary outcomes (12)

Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.
Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration.
Measured: Operative Visit
Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.
Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days.
Measured: Peri-op
Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.
Surgical Outcomes: To measure the amount of blood loss at the time of surgery.
Measured: Operative Visit
Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.
Medical Outcomes: Incidence of complications associated with the procedure and/or device.
Measured: 24 months
Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings
Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings
Measured: 24 months
Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.
Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings.
Measured: 24 months
Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.
Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings.
Measured: 24 months
Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).
Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS).
Measured: 24 months
Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.
Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations.
Measured: 24 months
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12.
Measured: 24 months
Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.
Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.
Measured: 24 months
Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.
Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 201619 Jan 2017

First posted10 Mar 2016 (estimated)
Study start8 Jun 2016
Primary completion19 Jan 2017
Study completion19 Jan 2017

Why it stopped: Lack of subject enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02704689
Sponsor's protocol ID: 2015-L-001
Other IDs: 510(k) 132505 & K143616
Acronym: APROPOS
Status last verified: Apr 2018
First submitted: 17 Feb 2016
Last updated: 24 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Lumbar Fusion With Nanotube Versus Titanium Cage
Degenerative Disc Disease, Lumbar Fusion

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine
ClinicalTrials.gov ID: NCT02704689
Acronym / sponsor ID: APROPOS / 2015-L-001
Conditions: Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of subject enrollment
Enrolment: 9 participants (actual)
Lead sponsor: VB Spine, LLCIndustry (pharma, biotech, devices)
Study start: 8 Jun 2016 (actual)
Primary completion: 19 Jan 2017 (actual)
Study completion: 19 Jan 2017 (actual)
First posted: 10 Mar 2016 (estimated)
Results: Posted 24 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AccuLIF	Experimental	Device: AccuLIF expandable TLIF cage

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject is skeletally mature and between 18 and 70 years of age.
DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.

Key exclusion criteria (26 listed)

Significant instability of the spine.
Requires TLIF at more than 2 levels between L2 and S1.
Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
Younger than 18 years of age, or older than 70 years of age.
BMI of 40 or greater.

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
AccuLIF expandable TLIF cageAccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.	Device	AccuLIF

Primary outcome

Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
Time frame: 24 months
Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.
Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.
Time frame: 24 months
Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.

12 secondary outcomes

Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.
Time frame: Operative Visit
Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.
Time frame: Peri-op
Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.
Time frame: Operative Visit
Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.
Time frame: 24 months
Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings
Time frame: 24 months
Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.
Time frame: 24 months
Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.
Time frame: 24 months
Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).
Time frame: 24 months
Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.
Time frame: 24 months
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.
Time frame: 24 months
Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.
Time frame: 24 months
Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.
Time frame: 24 months

Results and safety

Results posted to the registry on 24 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AccuLIF TL	9	6

Primary outcome: Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.

Time frame: 24 months

Population analysed: The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.

Primary outcome: Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.

Time frame: 24 months

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AccuLIF TL	2 of 9 (22.2%)	2 of 9 (22.2%)	0 of 9

Limitations and caveats (from the sponsor): A total of 100 subjects were planned for enrollment. However, this study was terminated early due to lack of enrollment with only 9 enrolled subjects and 6 treated subjects. No subjects reached the 24 month analysis visit.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Degenerative Disc Disease

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Lumbar Fusion With Nanotube Versus Titanium Cage
Degenerative Disc Disease, Lumbar Fusion

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.

Theodore Choma, MD principal investigator

University of Missouri Health Care

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AccuLIF expandable TLIF cage in people with Degenerative Disc Disease and Spondylolisthesis, Grade 1, run by VB Spine, LLC 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 6 inclusion and 26 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 24 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 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?

Yes. Results are posted in the registry (first posted 24 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02704689.

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 24 Apr 2018.