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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlareHawk Interbody Fusion System | Device | Expandable lumbar intervertebral body fusion device |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. | 12 months +/- 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo) |
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Inclusion Criteria:
To be a part of this study, the subject must:
Exclusion Criteria:
Subjects must not meet any of the following exclusion criteria to be included in the study:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Domagoj Coric, MD | Carolina Neurosurgery & Spine Associates, Charlotte, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chatham Orthopaedic Associates | Savannah | Georgia | 31405 | United States | ||
| Carolina Neurosurgery & Spine Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Retrospective Study Arm | Participants who previously underwent Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) surgery with the FlareHawk® expandable interbody fusion device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Retrospective Study Arm | Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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]. | Participants who had radiographs available at 12 months follow-up | Posted | Count of Participants | Participants | 12 months +/- 3 months |
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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).
Adverse Events were not monitored/assessed with regard to specific Adverse Event Terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Retrospective Study Arm | Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subsequent surgical intervention | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Revision surgery for failed supplemental instrumentation (pedicle screws or rods; not FlareHawk device) or adjacent segment disease. Adverse Events were not monitored/assessed with regard to specific Adverse Event Terms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild to Moderate Adverse Events | General disorders | Non-systematic Assessment | Other mild to moderate adverse events commonly associated with lumbar interbody fusion surgery. Adverse Events were not monitored/assessed with regard to specific Adverse Event Terms. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Kamer, Senior Director of Regulatory and Clinical Affairs | Integrity Implants Inc | +1.561.529.3861 | lkamer@integrityimplants.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2019 | Feb 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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). | 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. | From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo) |
| Charlotte |
| North Carolina |
| 28204 |
| United States |
| Northeast Ohio Spine Center | Akron | Ohio | 44333 | United States |
| years |
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| Sex: Female, Male | Gender of one subject not recorded in patient chart | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Smoking Status | Smoking status not available for 4 patients | Count of Participants | Participants |
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| Co-Morbidities | Count of Participants | Participants |
|
| Baseline VAS Leg Pain | Visual Analog Scale for Leg Pain; Scale = 0-10; 0 = No Pain; 10 = Worst Pain | Baseline VAS Leg Pain score was not recorded in patient chart for some subjects | Mean | Standard Deviation | units on a scale |
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| Baseline VAS Back Pain | Visual Analog Scale for Back Pain; Scale = 0-10; 0 = No Pain; 10 = Worst Pain | Baseline VAS Back Pain score was not recorded in patient chart for some subjects | Mean | Standard Deviation | units on a scale |
|
| Baseline ODI | Oswestry Disability Index; Scale = 0-100 0-20: Minimal disability 21-40: Moderate Disability 41-60: Severe Disability 61-80: Crippling back pain 81-100: Bed-bound | Baseline ODI score was not recorded in patient chart for some subjects | Mean | Standard Deviation | units on a scale |
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| Participants |
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| Secondary | 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). | Participants who had VAS Leg data available at both baseline and follow-up | Posted | Mean | Standard Deviation | score on a scale | From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo) |
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| Secondary | 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). | Participants who had VAS Back data at both baseline and follow-up | Posted | Mean | Standard Deviation | score on a scale | From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo) |
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| Secondary | 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. | Participants with both baseline and follow-up ODI data | Posted | Mean | Standard Deviation | score on a scale | From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo) |
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