Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

Integrity Implants Inc.129 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

129

Conditions

Degenerative Disc Disease

Interventions

FlareHawk Interbody Fusion SystemDEVICE

Expandable lumbar intervertebral body fusion device

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Chatham Orthopaedic Associates

Savannah, Georgia, United States

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, United States

Northeast Ohio Spine Center

Akron, Ohio, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

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)

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)

Data from ClinicalTrials.gov

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