Study of Lumbar Discectomy With Annular Closure

Lumbar Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03986580
• Other study ID #: CP-010
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Intrinsic Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Device:
• Annular closure device
Annular closure, following limited discectomy procedure at a single LS level between L4 and S1

Locations

Country	Name	City	State
United States	Indiana Spine Group	Carmel	Indiana
United States	North Shore University Health System	Evanston	Illinois
United States	Baptist - Lyerly Neurosurgery	Jacksonville	Florida
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky
United States	Salt Lake Orthopaedic Clinic	Salt Lake City	Utah
United States	UC San Diego Health System	San Diego	California
United States	Louisiana Spine Institute	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Intrinsic Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Amount of blood loss measured in ml	Intra-operative
Primary	Procedure time	Length of surgery, measured in minutes	Intra-operative
Primary	Hospital stay	Length of the hospital stay measured in days between hospital admission and hospital discharge	Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Primary	Discharge status	Evaluation of improvement in motor and sensory neurologic status	Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Primary	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	Baseline, 4 Weeks, 3 Months, 1 year
Primary	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	Baseline, 4 Weeks, 3 Months, 1 year
Primary	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	Baseline, 4 Weeks, 3 Months, 1 year
Primary	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	Baseline, 4 Weeks, 3 Months, 1 year
Primary	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	1 year
Primary	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	Baseline, 4 Weeks, 3 Months, 1 year
Primary	Adverse events	Change of health status with occurrence of adverse event, reported by seriousness and relationship to the device or procedure	Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
Primary	Hospital readmission occurrence	Change from baseline in incidence of re-admissions to hospital, post treatment	Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Primary	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	Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Primary	Reoperation incidence	Change from baseline in incidence of post-operative reoperation at the index level	Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Primary	Return to work assessment	Change from baseline in work status (ability to return to work, with or without reported restrictions)	4 Weeks, 3 Months, 1 year
Primary	Opioid consumption	Change from baseline for all opioid based medications (routes of administration (oral, IV, transdermal), dosing (mg/ml/tablet), duration (days)).	Baseline, Intra-operative, Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year