Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

NCT04057235 | Completed Results FDA Device

• 1 other identifier: CP-00001
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up

  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

  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

  From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo)

Interventions

FlareHawk Interbody Fusion System DEVICE

Expandable lumbar intervertebral body fusion device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrity Implants Inc.: lead

Study Sites (3)

Chatham Orthopaedic Associates

Savannah, Georgia, 31405, United States

Location

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Northeast Ohio Spine Center

Akron, Ohio, 44333, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

This was a retrospective study of patient chart data. No data was prospectively collected as part of this study. Therefore, follow-up data is limited among the overall cohort.

Results Point of Contact

• Title: Lauren Kamer, Senior Director of Regulatory and Clinical Affairs
• Organization: Integrity Implants Inc

lkamer@integrityimplants.com

+1.561.529.3861

Study Officials

• Domagoj Coric, MD

  Carolina Neurosurgery & Spine Associates, Charlotte, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: September 23, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 18, 2019
• Last Updated: April 21, 2020
• Results First Posted: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)