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.
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.
Study Type
OBSERVATIONAL
Enrollment
31
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.
Rush University Medical Center
Chicago, Illinois, United States
Fusion
Did patient achieve fusion?
Time frame: through study completion; 2 year
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Time frame: 6-week
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Time frame: 12- week
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Time frame: 6-month
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Time frame: 1-year
Visual Analogue Pain Scale: Back
0 to 10 score; higher score means worse pain
Time frame: 2-year
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Time frame: 6-week
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Time frame: 12- week
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Time frame: 6-month
Visual Analogue Pain Scale: Leg
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0 to 10 score; higher score means worse pain
Time frame: 1-year
Visual Analogue Pain Scale: Leg
0 to 10 score; higher score means worse pain
Time frame: 2-year
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Time frame: 6-week
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Time frame: 12- week
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Time frame: 6-month
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Time frame: 1-year
Oswestry Disability Index
0 to 100 score; higher score means greater patient disability
Time frame: 2-year
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Time frame: 6-week
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Time frame: 12-week
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Time frame: 6-month
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Time frame: 1-year
Short Form-12 Health Survey
0 to 100 score; higher score means less patient disability
Time frame: 2-year
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Time frame: 6-week
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Time frame: 12- week
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Time frame: 6-month
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Time frame: 1-year
Patient Reported Outcomes Measurement Information System (PROMIS)
20 to 80 score; higher score means higher reported self-capability
Time frame: 2-year