Trial Outcomes & Findings for Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion (NCT NCT04057235)

Last Updated: 2020-04-21

Results Overview

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 \[Bridwell and Lenke et al, 1995\].

Recruitment status

COMPLETED

Target enrollment

129 participants

Primary outcome timeframe

12 months +/- 3 months

Results posted on

2020-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	129
Overall Study Had Radiographic Data	58
Overall Study Had ODI Data	43
Overall Study Had VAS Back Data	45
Overall Study Had VAS Leg Data	45
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gender of one subject not recorded in patient chart

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Retrospective Study Arm n=129 Participants Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
Age, Continuous	60.5 years STANDARD_DEVIATION 12.7 • n=129 Participants
Sex: Female, Male Female	72 Participants n=128 Participants • Gender of one subject not recorded in patient chart
Sex: Female, Male Male	56 Participants n=128 Participants • Gender of one subject not recorded in patient chart
Region of Enrollment United States	129 Participants n=129 Participants
Body Mass Index (BMI)	31.3 kg/m^2 STANDARD_DEVIATION 7.3 • n=129 Participants
Smoking Status Non-smoker	73 Participants n=125 Participants • Smoking status not available for 4 patients
Smoking Status Active smoker	25 Participants n=125 Participants • Smoking status not available for 4 patients
Smoking Status Previous smoker	27 Participants n=125 Participants • Smoking status not available for 4 patients
Co-Morbidities Hypertension	53 Participants n=129 Participants
Co-Morbidities Diabetes	25 Participants n=129 Participants
Co-Morbidities Obesity (BMI >= 30)	61 Participants n=129 Participants
Co-Morbidities Hypercholesterolemia	8 Participants n=129 Participants
Co-Morbidities Coronary Heart Disease	9 Participants n=129 Participants
Co-Morbidities Hypothyroidism	6 Participants n=129 Participants
Co-Morbidities Active or History of Cancer	13 Participants n=129 Participants
Baseline VAS Leg Pain	6.8 units on a scale STANDARD_DEVIATION 2.9 • n=53 Participants • Baseline VAS Leg Pain score was not recorded in patient chart for some subjects
Baseline VAS Back Pain	7.7 units on a scale STANDARD_DEVIATION 2.1 • n=57 Participants • Baseline VAS Back Pain score was not recorded in patient chart for some subjects
Baseline ODI	55.0 units on a scale STANDARD_DEVIATION 17.5 • n=56 Participants • Baseline ODI score was not recorded in patient chart for some subjects

PRIMARY outcome

Timeframe: 12 months +/- 3 months

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

Outcome measures

Outcome measures
Measure	Single Retrospective Study Arm n=58 Participants Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
Radiographic Arthrodesis	56 Participants

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Single Retrospective Study Arm n=45 Participants Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
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

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Single Retrospective Study Arm n=45 Participants Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
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 outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Single Retrospective Study Arm n=43 Participants Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up	-14.6 score on a scale Standard Deviation 19.1

Adverse Events

Single Retrospective Study Arm

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Retrospective Study Arm n=129 participants at risk Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
Musculoskeletal and connective tissue disorders Subsequent surgical intervention	2.3% 3/129 • Number of events 3 • 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.

Other adverse events

Other adverse events
Measure	Single Retrospective Study Arm n=129 participants at risk Participants who previously underwent TLIF or PLIF surgery with the FlareHawk® expandable interbody fusion device.
General disorders Mild to Moderate Adverse Events	14.7% 19/129 • Number of events 22 • 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.

Additional Information

Lauren Kamer, Senior Director of Regulatory and Clinical Affairs

Integrity Implants Inc

Phone: +1.561.529.3861

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place