Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device

NCT ID: NCT02805985

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-06-30

Brief Summary

This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.

Detailed Description

As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in height. This enables larger footprint support as well as restoration of disc height and lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of insertion. The open architecture of the device allows it to be packed with autogenous bone graft.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLXfit™ TLIF Interbody Fusion Device

The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

Group Type: EXPERIMENTAL

FLXfit™ TLIF Interbody Fusion Device

Intervention Type: DEVICE

The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

Interventions

FLXfit™ TLIF Interbody Fusion Device

The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult (18-70 y/o)
• Male or Female
• With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:

• Degenerative disc disease with up to Grade I spondylolisthesis
• Spondylolisthesis
• Failure of at least 6-months conservative treatment
• BMI < 40
• Patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one
• Ability to read, understand, and sign informed consent

Exclusion Criteria

• Infection, local to the operative site
• Signs of local inflammation
• Fever or leukocytosis
• Pregnancy
• Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
• Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach
• Prior fusion procedure at an adjacent level
• Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
• Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
• Active local infection in or near the operative region
• Active systemic infection and/or disease
• Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
• Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
• Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs
• Suspected or documented allergy or intolerance to implant's materials
• Symptomatic cardiac disease
• Patient unwilling to cooperate with postoperative instructions.
• Any case where the implant components selected for use would be too large or too small to achieve a successful result.
• Patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
• Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
• Prior fusion at the level to be treated.
• Back VAS < 4/10

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: collaborator

Expanding Orthopedics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dustin H Massel, BS

Role: STUDY_DIRECTOR

Rush University Medical Center

Benjamin C Mayo, BA

Role: STUDY_DIRECTOR

Rush University Medical Center

Fady Hijji, BS

Role: STUDY_DIRECTOR

Rush University Medical Center

Kern Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center; Department of Orthopedic Surgery

Chicago, Illinois, United States

Countries

United States

Central Contacts

Kern Singh, MD

Role: CONTACT

kern.singh@rushortho.com

312-432-2373

Facility Contacts

Kern Singh, MD

Role: primary

kern.singh@rushortho.com

312-432-2373

Other Identifiers

FLXFit

Identifier Type: -

Identifier Source: org_study_id