FLXfitTM 15 TLIF Interbody Fusion Device

NCT04208048 | Completed FDA Device

• 1 other identifier: 18073011
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (26)

• Fusion

  Did patient achieve fusion?

  through study completion; 2 year

• Visual Analogue Pain Scale: Back

  0 to 10 score; higher score means worse pain

  6-week

• Visual Analogue Pain Scale: Back

  0 to 10 score; higher score means worse pain

  12- week

• Visual Analogue Pain Scale: Back

  0 to 10 score; higher score means worse pain

  6-month

• Visual Analogue Pain Scale: Back

  0 to 10 score; higher score means worse pain

  1-year

• Visual Analogue Pain Scale: Back

  0 to 10 score; higher score means worse pain

  2-year

• Visual Analogue Pain Scale: Leg

  0 to 10 score; higher score means worse pain

  6-week

• Visual Analogue Pain Scale: Leg

  0 to 10 score; higher score means worse pain

  12- week

• Visual Analogue Pain Scale: Leg

  0 to 10 score; higher score means worse pain

  6-month

• Visual Analogue Pain Scale: Leg

  0 to 10 score; higher score means worse pain

  1-year

• Visual Analogue Pain Scale: Leg

  0 to 10 score; higher score means worse pain

  2-year

• Oswestry Disability Index

  0 to 100 score; higher score means greater patient disability

  6-week

• Oswestry Disability Index

  0 to 100 score; higher score means greater patient disability

  12- week

• Oswestry Disability Index

  0 to 100 score; higher score means greater patient disability

  6-month

• Oswestry Disability Index

  0 to 100 score; higher score means greater patient disability

  1-year

• Oswestry Disability Index

  0 to 100 score; higher score means greater patient disability

  2-year

• Short Form-12 Health Survey

  0 to 100 score; higher score means less patient disability

  6-week

• Short Form-12 Health Survey

  0 to 100 score; higher score means less patient disability

  12-week

• Short Form-12 Health Survey

  0 to 100 score; higher score means less patient disability

  6-month

• Short Form-12 Health Survey

  0 to 100 score; higher score means less patient disability

  1-year

• Short Form-12 Health Survey

  0 to 100 score; higher score means less patient disability

  2-year

• Patient Reported Outcomes Measurement Information System (PROMIS)

  20 to 80 score; higher score means higher reported self-capability

  6-week

• Patient Reported Outcomes Measurement Information System (PROMIS)

  20 to 80 score; higher score means higher reported self-capability

  12- week

• Patient Reported Outcomes Measurement Information System (PROMIS)

  20 to 80 score; higher score means higher reported self-capability

  6-month

• Patient Reported Outcomes Measurement Information System (PROMIS)

  20 to 80 score; higher score means higher reported self-capability

  1-year

• Patient Reported Outcomes Measurement Information System (PROMIS)

  20 to 80 score; higher score means higher reported self-capability

  2-year

Study Arms (1)

FLXfit 15

The FLXfit 15 device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.

Device: FLXfit 15TM device

Interventions

FLXfit 15TM device DEVICE

In order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.

FLXfit 15

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment.

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

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Orthopedic Surgeon

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: December 23, 2019
• Study Start: October 15, 2018
• Primary Completion: March 1, 2022
• Study Completion: August 22, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available after the participant has signed the informed consent and will remain available until the study is closed.
• Access Criteria: The study staff will have to complete HIPPA and confidentiality training. In addition, they must by Midwest Orthopedics staff who will access the information on a password protected and encrypted computer.

Locations

US (1)