Study of Lumbar Discectomy With Annular Closure

NCT03986580 | Unknown DMC FDA Device

• 1 other identifier: CP-010
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 7

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (16)

• Blood loss

  Amount of blood loss measured in ml

  Intra-operative

• Procedure time

  Length of surgery, measured in minutes

  Intra-operative

• 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)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Annular closure device

OTHER

Single arm study; all patients treated with an annular closure device

Device: Annular closure device

Interventions

Annular closure device DEVICE

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

Annular closure device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.
• 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.)
• 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.
• Subject has insulin-dependent diabetes mellitus.
• Subject is morbidly obese (defined as a body mass index \>40, or weighs more than 100 lbs over ideal body weight).

Sponsors & Collaborators

• Intrinsic Therapeutics: lead

Study Sites (7)

UC San Diego Health System

San Diego, California, 92037, United States

Location

Baptist - Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

Louisiana Spine Institute

Shreveport, Louisiana, 71101-4643, United States

Location

Salt Lake Orthopaedic Clinic

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• 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.

  PMID: 31464935 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David H Kim, MD

  New England Baptist Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: May 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (7)