Return to Activity After Surgery for Lumbar Disc Herniation (NCT07667348) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Return to Activity After Surgery for Lumbar Disc Herniation
United States120 participantsStarted 2026-06-30
Plain-language summary
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptomatic reherniation
Timeframe: 3 Months
Trial details
NCT IDNCT07667348
SponsorIntrinsic Therapeutics
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-10-01
Contact for this trial
Kelsey Miller-Torchia A SVP, Clinical & Business Development, BA