Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: FlareHawk Interbody Fusion System

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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 exclusion criteria to be included in the study:

1. Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)
2. Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
3. Have had surgery with the FlareHawk device(s) at more than 2 levels
4. Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1
5. Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding disc space
6. Have any contraindications listed in the approved labeling

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Integrity Implants Inc.
• Investigators: Principal Investigator: Domagoj Coric, MD, Carolina Neurosurgery & Spine Associates, Charlotte, NC

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CP-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes