Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057235
• Other study ID #: CP-00001
• Status: Completed
• Start date: September 23, 2019
• Est. completion date: December 18, 2019

Study information

• Verified date: April 2020
• Source: Integrity Implants Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 18, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• FlareHawk Interbody Fusion System
Expandable lumbar intervertebral body fusion device

Locations

Country	Name	City	State
United States	Northeast Ohio Spine Center	Akron	Ohio
United States	Carolina Neurosurgery & Spine Associates	Charlotte	North Carolina
United States	Chatham Orthopaedic Associates	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Integrity Implants Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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].	12 months +/- 3 months
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).	From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo)
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).	From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo)
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.	From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo)