Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion

Integrity Implants

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Device: FlareHawk Interbody Fusion System

Study type: Observational

Funder types: Industry

Identifiers

NCT04057235

CP-00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design