The purpose of this prospective, single-arm, multicenter study is to assess an annular closure device when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone.
This single-arm case series will enroll 75 patients at select US (approximately 8-10) sites. Patients that are scheduled for a single-level L4-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients that meet all intraoperative criteria will be enrolled into the study and treated with lumbar discectomy and additional annular closure device implantation. All enrolled subjects will be followed for at least 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Annular closure, following limited discectomy procedure at a single LS level between L4 and S1
UC San Diego Health System
San Diego, California, United States
Baptist - Lyerly Neurosurgery
Jacksonville, Florida, United States
North Shore University Health System
Evanston, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Blood loss
Amount of blood loss measured in ml
Time frame: Intra-operative
Procedure time
Length of surgery, measured in minutes
Time frame: Intra-operative
Hospital stay
Length of the hospital stay measured in days between hospital admission and hospital discharge
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Discharge status
Evaluation of improvement in motor and sensory neurologic status
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Leg pain severity (0-100 VAS score)
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Back pain severity (0-100 VAS score)
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
ODI
Change from baseline in Oswestry Disability Index. The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
EQ-5D
Change from baseline in EQ-5D. The EuroQol (EQ-5D) is a generic utility measure used to characterize current health states. The subject-reported questionnaire consists of 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which can take one of three responses. Possible responses include three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
Louisiana Spine Institute
Shreveport, Louisiana, United States
Salt Lake Orthopaedic Clinic
Salt Lake City, Utah, United States
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Satisfaction with surgery procedure
Patient satisfaction with surgery and treatment assessed utilizing questionnaire with Composite questionnaire with 2 questions will be administered; 1.) Indicate degree of satisfaction with the outcome and 2.) likelihood of recommending the procedure to others
Time frame: 1 year
Neurological assessment
Change from baseline in sensory (sensation response at dermatomal levels) reflex, (knee jerk, ankle jerk, response measured as "normal", "increased", "absent" and "decreased") and muscle strength measured 0-5 with "0" representing no evidence of motor strength and "5" representing full resistance
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Adverse events
Change of health status with occurrence of adverse event, reported by seriousness and relationship to the device or procedure
Time frame: Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
Hospital readmission occurrence
Change from baseline in incidence of re-admissions to hospital, post treatment
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Symptomatic reherniation incidence
Change from baseline in incidence of post-operative recurrent herniation at the index level. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Reoperation incidence
Change from baseline in incidence of post-operative reoperation at the index level
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Return to work assessment
Change from baseline in work status (ability to return to work, with or without reported restrictions)
Time frame: 4 Weeks, 3 Months, 1 year
Opioid consumption
Change from baseline for all opioid based medications (routes of administration (oral, IV, transdermal), dosing (mg/ml/tablet), duration (days)).
Time frame: Baseline, Intra-operative, Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year