Return to Activity After Surgery for Lumbar Disc Herniation

Starting soon · Phase 4

Conditions studied: Lumbar Disc Herniation Surgery, Disc Herniation

In brief

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

Key facts

Study ID: NCT07667348
Run by: Intrinsic Therapeutics
People needed: 120
Starts: 2026-06-30
Expected to finish: 2027-10-31
Last updated by the study team: 2026-06-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.
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.

Where it is running

Spine Institute of Louisiana — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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