Clinical trial NCT03986580: Study of Lumbar Discectomy With Annular Closure
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Intrinsic Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 75 years old and skeletally mature (male or female)
2. Subjects with posterior or posterolateral disc herniations at one level between L4 and S1 with radiographic confirmation of neural compression using MRI. \[Note: Intraoperatively, only patients with an anular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.\]
3. 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.;
4. Minimum posterior disc height of 5mm at the index level.
5. Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)
6. Oswestry Questionnaire score of at least 40/100 at baseline.
7. VAS leg pain (one or both legs) of at least 40/100 at baseline.
8. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

1. Spondylolisthesis Grade II or higher (25% slip or greater).
2. Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain (scar tissue and osteophyte removal is allowed).
3. Subject has back or non-radicular leg pain of unknown etiology.
4. Prior surgery at the index lumbar vertebral level
5. 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.
6. Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
7. Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip
8. Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
9. Any metabolic bone disease.
10. Subject has an active infection either systemic or local.
11. Subject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.
12. Subject has severe arterial insufficiency of the legs or other peripheral vascular disease. (Screening on physical examination for patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded.)
13. Subject has significant peripheral neuropathy, defined as a subject with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.
14. Subject has insulin-dependent diabetes mellitus.
15. Subject is morbidly obese (defined as a body mass index \>40, or weighs more than 100 lbs over ideal body weight).
16. Subject has been diagnosed with active hepatitis, AIDS, or HIV.
17. Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
18. Subject has a known allergy to titanium, polyethylene or polyester materials.
19. Any subject that cannot have a baseline MRI taken.
20. Subject is pregnant or interested in becoming pregnant in the next 2 years.
21. Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
22. Subject has a history of active malignancy: A subject with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.
23. Subject is immunologically suppressed, received steroids \>1 month over the past year.
24. Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.
25. Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
26. Subject has a life expectancy of less than three (3) years.
27. Subject is currently involved in active spinal litigation.
28. Subject is currently involved in another investigational study.
29. Subject is incarcerated.
30. Any contraindication for MRI (e.g. claustrophobia, contrast allergy).

Primary outcomes:
measure: Blood loss
timeFrame: Intra-operative
measure: Procedure time
timeFrame: Intra-operative
measure: Hospital stay
timeFrame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
measure: Discharge status
timeFrame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
measure: Leg pain severity (0-100 VAS score)
timeFrame: Baseline, 4 Weeks, 3 Months, 1 year
measure: Back pain severity (0-100 VAS score)
timeFrame: Baseline, 4 Weeks, 3 Months, 1 year
measure: ODI
timeFrame: Baseline, 4 Weeks, 3 Months, 1 year
measure: EQ-5D
timeFrame: Baseline, 4 Weeks, 3 Months, 1 year
measure: Satisfaction with surgery procedure
timeFrame: 1 year
measure: Neurological assessment
timeFrame: Baseline, 4 Weeks, 3 Months, 1 year
measure: Adverse events
timeFrame: Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
measure: Hospital readmission occurrence
timeFrame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
measure: Symptomatic reherniation incidence
timeFrame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
measure: Reoperation incidence
timeFrame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
measure: Return to work assessment
timeFrame: 4 Weeks, 3 Months, 1 year
measure: Opioid consumption
timeFrame: Baseline, Intra-operative, Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Health System
state: California
city: Jacksonville
country: United States
facility: Baptist - Lyerly Neurosurgery
state: Florida
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Spine Institute
state: Louisiana
city: Salt Lake City
country: United States
facility: Salt Lake Orthopaedic Clinic
state: Utah
Study officials:
affiliation: New England Baptist Hospital
name: David H Kim, MD
role: STUDY_CHAIR
References:
citation: Strenge KB, DiPaola CP, Miller LE, Hill CP, Whitmore RG. Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol. Medicine (Baltimore). 2019 Aug;98(35):e16953. doi: 10.1097/MD.0000000000016953.