Degenerative Disc Disease
Conditions
Brief 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.
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.
Interventions
DEVICEFlareHawk Interbody Fusion System
Expandable lumbar intervertebral body fusion device
Sponsors
Integrity Implants Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be a part of this study, the subject must: 1. Have been at least 18 years of age and skeletally mature at the time of surgery 2. Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine 3. 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 4. Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, between December 1, 2017, and May 31, 2018
Exclusion criteria
Subjects must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Arthrodesis | 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 \[Bridwell and Lenke et al, 1995\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up | From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo) | 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). |
| Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up | From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo) | 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). |
| Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up | From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Retrospective Study Arm Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device. | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | Single Retrospective Study Arm | — |
|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 12.7 | — |
| Baseline ODI | 55.0 units on a scale STANDARD_DEVIATION 17.5 | — |
| Baseline VAS Back Pain | 7.7 units on a scale STANDARD_DEVIATION 2.1 | — |
| Baseline VAS Leg Pain | 6.8 units on a scale STANDARD_DEVIATION 2.9 | — |
| Body Mass Index (BMI) | 31.3 kg/m^2 STANDARD_DEVIATION 7.3 | — |
| Co-Morbidities Active or History of Cancer | 13 Participants | — |
| Co-Morbidities Coronary Heart Disease | 9 Participants | — |
| Co-Morbidities Diabetes | 25 Participants | — |
| Co-Morbidities Hypercholesterolemia | 8 Participants | — |
| Co-Morbidities Hypertension | 53 Participants | — |
| Co-Morbidities Hypothyroidism | 6 Participants | — |
| Co-Morbidities Obesity (BMI >= 30) | 61 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 129 Participants | — |
| Sex: Female, Male Female | 72 Participants | — |
| Sex: Female, Male Male | 56 Participants | — |
| Smoking Status Active smoker | 25 Participants | — |
| Smoking Status Non-smoker | 73 Participants | — |
| Smoking Status Previous smoker | 27 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 19 / 129 |
| serious Total, serious adverse events | 3 / 129 |
Outcome results
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 \[Bridwell and Lenke et al, 1995\].
Time frame: 12 months +/- 3 months
Population: Participants who had radiographs available at 12 months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Retrospective Study Arm | Radiographic Arthrodesis | 56 Participants |
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.
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)
Population: Participants with both baseline and follow-up ODI data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Retrospective Study Arm | Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up | -14.6 score on a scale | Standard Deviation 19.1 |
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).
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)
Population: Participants who had VAS Back data at both baseline and follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Retrospective Study Arm | Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up | -3.4 score on a scale | Standard Deviation 2.6 |
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).
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)
Population: Participants who had VAS Leg data available at both baseline and follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Retrospective Study Arm | Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up | -3.9 score on a scale | Standard Deviation 3.4 |