NCT07667348

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
15mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Oct 2027

First Submitted

Initial submission to the registry

June 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 18, 2026

Last Update Submit

June 18, 2026

Conditions

Lumbar Disc Herniation SurgeryDisc Herniation

Keywords

Lumbar discectomypostoperative instructionslumbar disc herniation

Outcome Measures

Primary Outcomes (1)

  • Symptomatic reherniation

    No symptomatic reherniation at the index level (on either side)

    3 Months

Study Arms (2)

Non restricted postoperative instructions

EXPERIMENTAL

Non restricted postoperative instructions

Other: Postoperative therapy

Restricted postoperative instructions

ACTIVE COMPARATOR

Restricted postoperative instructions

Other: Postoperative therapy

Interventions

Postoperative therapyOTHER

Investigating different postoperative restrictions after lumbar disc herniation surgery

Non restricted postoperative instructionsRestricted postoperative instructions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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 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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • David H Kim, MD

    Atrius Health

    STUDY CHAIR

Central Study Contacts

Kelsey Miller-Torchia A SVP, Clinical & Business Development, BA

CONTACT

7819320222kmiller@barricaid.com

Ivan Grzan Sr. Dir. Professional Education, BA

CONTACT

7819320222ivan@in-thera.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 25, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

No external collaboration expected

Locations

US(1)