FLXfitTM 15 TLIF Interbody Fusion Device

Degenerative Disc Disease Clinical Trial

Official title:

Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208048
• Other study ID #: 18073011
• Status: Completed
• Start date: October 15, 2018
• Est. completion date: August 22, 2022

Study information

• Verified date: March 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 (study device) system, as measured by the rate of serious operative and post-operative complications. It will also assess the effectiveness as measured by radiographs (X-rays), CT scans, MRI scans, patient-reported, health-related quality of life questionnaires up to (24) months following the procedure, as compared to before surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 22, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• FLXfit 15TM 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion	Did patient achieve fusion?	through study completion; 2 year
Primary	Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	6-week
Primary	Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	12- week
Primary	Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	6-month
Primary	Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	1-year
Primary	Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	2-year
Primary	Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	6-week
Primary	Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	12- week
Primary	Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	6-month
Primary	Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	1-year
Primary	Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	2-year
Primary	Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	6-week
Primary	Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	12- week
Primary	Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	6-month
Primary	Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	1-year
Primary	Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	2-year
Primary	Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	6-week
Primary	Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	12-week
Primary	Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	6-month
Primary	Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	1-year
Primary	Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	2-year
Primary	Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	6-week
Primary	Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	12- week
Primary	Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	6-month
Primary	Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	1-year
Primary	Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	2-year