Degenerative Disc DiseaseNCT04057235

Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

An observational study of Degenerative Disc Disease, run by Integrity Implants Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a retrospective clinical study (chart review) of patients who have previously undergone Transforaminal Lumbar Interbody Fusion or Posterior Lumbar Interbody Fusion surgery with the FlareHawk expandable interbody fusion cage at one or two contiguous levels. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Degenerative Disc Disease
What is being tested?: FlareHawk Interbody Fusion System
Type of treatment: Medical device
How many people: 129 participants
Where: 3 sitesUnited States
Study dates: 23 Sep 2019to 18 Dec 2019
Phase: Observational
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: A total of at least 100 patients from at least three sites will be enrolled based on inclusion/exclusion criteria. The retrospective chart review will include the full consecutive series of patients who received TLIF or PLIF surgery using the FlareHawk expandable interbody fusion cage between December 1, 2017, and May 31, 2018. Subjects from that consecutive series will be included in the study based on the pre-defined inclusion and exclusion criteria. All subjects will have been diagnosed with degenerative disc disease of the lumbar spine that required lumbar interbody fusion procedure at one or two levels as per the opinion of the treating surgeon. All subjects who meet the inclusion criteria and do not meet any of the exclusion criteria will be included in the study

Who may be able to join

To be a part of this study, the subject must:
Have been at least 18 years of age and skeletally mature at the time of surgery
Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine
Have been treated with PLIF or TLIF surgery using the FlareHawk expandable interbody cage(s) at 1 or 2 contiguous levels from L2 to S1
Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, between December 1, 2017, and May 31, 2018

Who cannot join

Subjects must not meet any of the following exclusion criteria to be included in the study:
Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)
Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
Have had surgery with the FlareHawk device(s) at more than 2 levels
Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1
Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding disc space
Have any contraindications listed in the approved labeling

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Northeast Ohio Spine Center
Akron, Ohio, 44333
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204
Chatham Orthopaedic Associates
Savannah, Georgia, 31405

Other trials in United States

About this study

Official title: Transforaminal/Posterior Lumbar Interbody Fusion With the FlareHawk® Expandable Interbody Fusion Device: A Retrospective Chart Review Study

Read the detailed description

The purpose of this study is to evaluate the clinical outcomes of patients who have undergone a Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedure with a FlareHawk expandable interbody fusion cage(s) to assess the device's performance and safety when used in accordance with its intended use. The primary hypothesis is that study subjects who received the FlareHawk expandable cage(s) through a TLIF or PLIF procedure experienced fusion by 12 months (+/- 3 mo) follow-up, with improvements in clinical outcomes related to pain and/or disability compared to pre-operative scores. Further, the subjects are hypothesized to have not experienced any unforeseen device- or procedure-related adverse events.

Conditions: Degenerative Disc Disease
Being tested: FlareHawk Interbody Fusion System
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.

FlareHawk Interbody Fusion SystemDevice
Expandable lumbar intervertebral body fusion device

What is being measured

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

Radiographic Arthrodesis
Proportion of participants with radiographic arthrodesis at 12 months +/- 3 months as determined using plain radiographic images with assessment based on the Bridwell-Lenke grading system [Bridwell and Lenke et al, 1995].
Measured: 12 months +/- 3 months

Secondary outcomes (3)

Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up
Visual analog scale for measuring pain intensity related to leg pain. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Measured: From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo)
Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up
Visual analog scale for measuring pain intensity related to back pain. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Measured: From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo)
Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up
ODI is used to quantify disability related to lower back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo)

Timeline

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

23 Sep 201918 Dec 2019

First posted15 Aug 2019
Study start23 Sep 2019
Primary completion13 Dec 2019
Study completion18 Dec 2019

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: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04057235
Sponsor's protocol ID: CP-00001
Status last verified: Apr 2020
First submitted: 13 Aug 2019
Last updated: 21 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
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

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Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
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Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
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All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transforaminal/Posterior Lumbar Interbody Fusion With the FlareHawk® Expandable Interbody Fusion Device: A Retrospective Chart Review Study
ClinicalTrials.gov ID: NCT04057235
Acronym / sponsor ID: CP-00001
Conditions: Degenerative Disc Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Integrity Implants Inc.Industry (pharma, biotech, devices)
Study start: 23 Sep 2019 (actual)
Primary completion: 13 Dec 2019 (actual)
Study completion: 18 Dec 2019 (actual)
First posted: 15 Aug 2019 (actual)
Results: Posted 14 Apr 2020

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

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: A total of at least 100 patients from at least three sites will be enrolled based on inclusion/exclusion criteria. The retrospective chart review will include the full consecutive series of patients who received TLIF or PLIF surgery using the FlareHawk expandable interbody fusion cage between December 1, 2017, and May 31, 2018. Subjects from that consecutive series will be included in the study based on the pre-defined inclusion and exclusion criteria. All subjects will have been diagnosed with degenerative disc disease of the lumbar spine that required lumbar interbody fusion procedure at one or two levels as per the opinion of the treating surgeon. All subjects who meet the inclusion criteria and do not meet any of the exclusion criteria will be included in the study

Key inclusion criteria (5 listed)

Have been at least 18 years of age and skeletally mature at the time of surgery
Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine
Have been treated with PLIF or TLIF surgery using the FlareHawk expandable interbody cage(s) at 1 or 2 contiguous levels from L2 to S1
Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, between December 1, 2017, and May 31, 2018

Key exclusion criteria (7 listed)

Subjects must not meet any of the following exclusion criteria to be included in the study:
Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)
Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
Have had surgery with the FlareHawk device(s) at more than 2 levels
Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1

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
FlareHawk Interbody Fusion SystemExpandable lumbar intervertebral body fusion device	Device	–

Primary outcome

Radiographic Arthrodesis
Time frame: 12 months +/- 3 months
Proportion of participants with radiographic arthrodesis at 12 months +/- 3 months as determined using plain radiographic images with assessment based on the Bridwell-Lenke grading system [Bridwell and Lenke et al, 1995].

3 secondary outcomes

Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up
Time frame: From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo)
Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up
Time frame: From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo)
Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up
Time frame: From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo)

Results and safety

Results posted to the registry on 14 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Retrospective Study Arm	129	129

Primary outcome: Radiographic Arthrodesis

Time frame: 12 months +/- 3 months. Count of participants. Unit: Participants

Measure	Single Retrospective Study Arm n = 58
Value	56

Population analysed: Participants who had radiographs available at 12 months follow-up

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected at the time of surgery (intraoperative adverse events) and through last patient follow-up, with an average follow-up time of 8.0 ± 4.9 months (range: 0.5-20.5 mo).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Retrospective Study Arm	3 of 129 (2.3%)	19 of 129 (14.7%)	0 of 129

Limitations and caveats (from the sponsor): This was a retrospective study of patient chart data. No data was prospectively collected as part of this study. Therefore, follow-up data is limited among the overall cohort.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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
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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.

Domagoj Coric, MD principal investigator

Carolina Neurosurgery & Spine Associates, Charlotte, NC

3 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, run by Integrity Implants Inc. at 3 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 5 inclusion and 7 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 14 Apr 2020). 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?

Radiographic Arthrodesis (time frame: 12 months +/- 3 months). 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 NCT04057235.

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 21 Apr 2020.