Lumbar Disc Herniation SurgeryPhase 4NCT07667348
Return to Activity After Surgery for Lumbar Disc Herniation
A Phase 4 study testing Postoperative therapy in people with Lumbar Disc Herniation Surgery and Disc Herniation, run by Intrinsic Therapeutics at 1 site in United States.
Trial summary
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Disc Herniation Surgery, Disc Herniation
- What is being tested?
- Postoperative therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelsey Miller-Torchia A SVP, Clinical & Business Development, BA contact
United States1 site
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Heather Bowman, RN, 318-629-6337, hbowman@saon.net
Krista Kachnik, BS, 3186296338, kkachnik@saon.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Disc Herniation Surgery, Disc Herniation
- Being tested
- Postoperative therapy
- Keywords
- Lumbar discectomy, postoperative instructions, lumbar disc herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative therapyOther
Investigating different postoperative restrictions after lumbar disc herniation surgery
| Study group | Role | What they receive |
|---|---|---|
| Non restricted postoperative instructions | Experimental | Non restricted postoperative instructions Receives: Other: Postoperative therapy |
| Restricted postoperative instructions | Active comparator | Restricted postoperative instructions Receives: Other: Postoperative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic reherniation
No symptomatic reherniation at the index level (on either side)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Herniation SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intrinsic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David H Kim, MD, Study chair, Atrius Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667348
- Sponsor's protocol ID
- CP-015
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No external collaboration expected
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Activity After Surgery for Lumbar Disc Herniation: An Exploratory, Post-Market, Prospective, Randomized, Controlled Trial of an Annular Closure Device
- ClinicalTrials.gov ID
- NCT07667348
- Acronym / sponsor ID
- CP-015
- Conditions
- Lumbar Disc Herniation Surgery, Disc Herniation
- Keywords
- Lumbar discectomy, postoperative instructions, lumbar disc herniation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Intrinsic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non restricted postoperative instructions | Experimental | Other: Postoperative therapyNon restricted postoperative instructions |
| Restricted postoperative instructions | Active comparator | Other: Postoperative therapyRestricted postoperative instructions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative therapyInvestigating different postoperative restrictions after lumbar disc herniation surgery | Other | Non restricted postoperative instructions, Restricted postoperative instructions |
Primary outcome
Symptomatic reherniation
Time frame: 3 Months
No symptomatic reherniation at the index level (on either side)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No. No external collaboration expected
Related trials for Lumbar Disc Herniation Surgery
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Recruiting
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Spinal Stenosis Lumbar, Disc Herniation, Lumbar
Recruiting
Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery
Lumbar Disc Herniation, Lumbar Spinal Stenosis
Recruiting
Postoperative Pain and Analgesic Use Following Lumbar Discectomy: A Comparative Study of Endoscopic Surgery and Open Surgery
Herniated Lumbar Disc
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelsey Miller-Torchia A SVP, Clinical & Business Development, BA contact
David H Kim, MD study chair
Atrius Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Postoperative therapy in people with Lumbar Disc Herniation Surgery and Disc Herniation, run by Intrinsic Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Miller-Torchia A SVP, Clinical & Business Development, BA (7819320222 ext. 322, kmiller@barricaid.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic reherniation (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.