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Completed

NCT Number: NCT04057235

Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chatham Orthopaedic Associates, Savannah, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

FlareHawk Interbody Fusion System

Device

Expandable lumbar intervertebral body fusion device

Primary outcomes

  1. 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].

Secondary outcomes

  1. 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)

    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).

  2. 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)

    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).

  3. 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)

    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.

Sponsors and collaborators

Lead sponsor

Integrity Implants Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2019
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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