Prospective Evaluation Of Lumbar Discectomy With Additional Implantation Of An Annular Closure Device In Patients With Large Postsurgical Annular Defects For Prevention Of Lumbar Disc Reherniation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Disc Herniation
- Sponsor
- Intrinsic Therapeutics
- Enrollment
- 55
- Locations
- 7
- Primary Endpoint
- Hospital readmission occurrence
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 75 years old and skeletally mature (male or female)
- •Subjects with posterior or posterolateral disc herniations at one level between L4 and S1 with radiographic confirmation of neural compression using MRI. \[Note: Intraoperatively, only patients with an anular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.\]
- •At least six (6) weeks of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.;
- •Minimum posterior disc height of 5mm at the index level.
- •Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)
- •Oswestry Questionnaire score of at least 40/100 at baseline.
- •VAS leg pain (one or both legs) of at least 40/100 at baseline.
- •Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Exclusion Criteria
- •Spondylolisthesis Grade II or higher (25% slip or greater).
- •Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain (scar tissue and osteophyte removal is allowed).
- •Subject has back or non-radicular leg pain of unknown etiology.
- •Prior surgery at the index lumbar vertebral level
- •Subject requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.
- •Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
- •Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip
- •Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
- •Any metabolic bone disease.
- •Subject has an active infection either systemic or local.
Outcomes
Primary Outcomes
Hospital readmission occurrence
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of re-admissions to hospital, post treatment
Procedure time
Time Frame: Intra-operative
Length of surgery, measured in minutes
ODI
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
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
Neurological assessment
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
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
Leg pain severity (0-100 VAS score)
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Satisfaction with surgery procedure
Time Frame: 1 year
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
Adverse events
Time Frame: Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
Change of health status with occurrence of adverse event, reported by seriousness and relationship to the device or procedure
Blood loss
Time Frame: Intra-operative
Amount of blood loss measured in ml
Hospital stay
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Length of the hospital stay measured in days between hospital admission and hospital discharge
Back pain severity (0-100 VAS score)
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
EQ-5D
Time Frame: Baseline, 4 Weeks, 3 Months, 1 year
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
Reoperation incidence
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of post-operative reoperation at the index level
Return to work assessment
Time Frame: 4 Weeks, 3 Months, 1 year
Change from baseline in work status (ability to return to work, with or without reported restrictions)
Discharge status
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Evaluation of improvement in motor and sensory neurologic status
Symptomatic reherniation incidence
Time Frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
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
Opioid consumption
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
Change from baseline for all opioid based medications (routes of administration (oral, IV, transdermal), dosing (mg/ml/tablet), duration (days)).