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

NCT02805985 | Unknown DMC

• 1 other identifier: FLXFit
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis

Keywords

Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis

Outcome Measures

Primary Outcomes (1)

• Safety/Adverse Events

  All adverse events will be assessed by incidence and time to resolution of postoperative device-related complications and serious adverse events/incidence and time to reoperation/incidence and time to revision. All perioperative adverse events will be noted. Information will be obtained from the operative note regarding blood loos, length of surgery, procedural details and complications. Postoperative events including nausea, vomiting, wound complications, thromboembolic events will be assessed.

  Up to 24 months

Secondary Outcomes (9)

• Disability

  24 months

• Change in Disability

  Up to 24 months

• Pain

  24 months

• Change in Pain

  Up to 24 months

• Health-Related Quality of Life Questionnaire

  24 months

Study Arms (1)

FLXfit™ TLIF Interbody Fusion Device

EXPERIMENTAL

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.

Device: FLXfit™ TLIF Interbody Fusion Device

Interventions

FLXfit™ TLIF Interbody Fusion Device 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.

FLXfit™ TLIF Interbody Fusion Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Expanding Orthopedics Ltd.: lead
• Rush University Medical Center: collaborator

Study Sites (1)

Rush University Medical Center; Department of Orthopedic Surgery

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Dustin H Massel, BS

  Rush University Medical Center

  STUDY DIRECTOR

• Benjamin C Mayo, BA

  Rush University Medical Center

  STUDY DIRECTOR

• Fady Hijji, BS

  Rush University Medical Center

  STUDY DIRECTOR

• Kern Singh, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kern Singh, MD

CONTACT

312-432-2373; kern.singh@rushortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 20, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 25, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)