Return to Activity After Surgery for Lumbar Disc Herniation

Return to Activity After Surgery for Lumbar Disc Herniation: An Exploratory, Post-Market, Prospective, Randomized, Controlled Trial of an Annular Closure Device

RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.

Study Overview

• Status: Not yet recruiting
• Conditions: Disc Herniation; Lumbar Disc Herniation Surgery
• Intervention / Treatment: Other: Postoperative therapy

Detailed Description

The purpose of this prospective, randomized, multicenter study is to determine the reherniation and reoperation rates of patients treated with the annular closure device after standard post-operative restrictions versus patient-determined restrictions.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kelsey Miller-Torchia A SVP, Clinical & Business Development, BA; Phone Number: 322 7819320222; Email: kmiller@barricaid.com
• Study Contact Backup: Name: Ivan Grzan Sr. Dir. Professional Education, BA; Phone Number: 7819320222; Email: ivan@in-thera.com

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
      • Principal Investigator: Pierce Nunley, MD
      • Contact: Heather Bowman, RN; Phone Number: 318-629-6337; Email: hbowman@saon.net
      • Contact: Krista Kachnik, BS; Phone Number: 3186296338; Email: kkachnik@saon.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Skeletally mature (male or female).
• Patients 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 annular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.]
• 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)22 (L45, L5S1)
• 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.
• Implanted with annular closure device.

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 been diagnosed with active hepatitis, AIDS, or HIV.
• Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
• Subject has a known allergy to titanium, polyethylene or polyester materials.
• Any subject that cannot have a baseline MRI taken.
• Subject is pregnant or interested in becoming pregnant in the next year.
• Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
• Subject has a history of active malignancy: A patient 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.
• Subject is immunologically suppressed, received steroids >1 month over the past year.
• Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.
• Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
• Subject has a life expectancy of less than three (3) years.
• Subject is currently involved in active spinal litigation (Workers' compensation patients may be included.
• Subject is currently involved in another investigational study.
• Subject is incarcerated.
• 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, patient defined as a patient 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non restricted postoperative instructions	Other: Postoperative therapy; Investigating different postoperative restrictions after lumbar disc herniation surgery
Active Comparator: Restricted postoperative instructions	Other: Postoperative therapy; Investigating different postoperative restrictions after lumbar disc herniation surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic reherniation	No symptomatic reherniation at the index level (on either side)	3 Months

Collaborators and Investigators

• Sponsor: Intrinsic Therapeutics
• Investigators: Study Chair: David H Kim, MD, Atrius Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: lumbar disc herniation; Lumbar discectomy; postoperative instructions
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Intervertebral Disc Displacement
• Other Study ID Numbers: CP-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No external collaboration expected

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No