Lumbar Disc HerniationNCT03986580
Study of Lumbar Discectomy With Annular Closure
A study testing Annular closure device in people with Lumbar Disc Herniation, run by Intrinsic Therapeutics at 7 sites in United States.
Trial summary
The purpose of this prospective, single-arm, multicenter study is to assess an annular closure device when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Annular closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old and skeletally mature (male or female)
- Subjects 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 anular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.]
- At least six (6) weeks of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.;
- 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)
- Oswestry Questionnaire score of at least 40/100 at baseline.
- 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.
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 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.
Show all 30Show fewer
- 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, defined as a subject 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).
- 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 2 years.
- Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
- Subject has a history of active malignancy: A subject 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.
- Subject is currently involved in another investigational study.
- Subject is incarcerated.
- Any contraindication for MRI (e.g. claustrophobia, contrast allergy).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Indiana Spine Group
Carmel, Indiana, 46032
North Shore University Health System
Evanston, Illinois, 60201
Baptist - Lyerly Neurosurgery
Jacksonville, Florida, 32207
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
Salt Lake Orthopaedic Clinic
Salt Lake City, Utah, 84124
UC San Diego Health System
San Diego, California, 92037
Louisiana Spine Institute
Shreveport, Louisiana, 71101-4643
About this study
Official title: Prospective Evaluation Of Lumbar Discectomy With Additional Implantation Of An Annular Closure Device In Patients With Large Postsurgical Annular Defects For Prevention Of Lumbar Disc Reherniation
The purpose of this prospective, single-arm, multicenter study is to assess an annular closure device when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone.
Read the detailed description
This single-arm case series will enroll 75 patients at select US (approximately 8-10) sites. Patients that are scheduled for a single-level L4-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients that meet all intraoperative criteria will be enrolled into the study and treated with lumbar discectomy and additional annular closure device implantation. All enrolled subjects will be followed for at least 12 months.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Annular closure device
- 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.
Annular closure deviceDevice
Annular closure, following limited discectomy procedure at a single LS level between L4 and S1
| Study group | Role | What they receive |
|---|---|---|
| Annular closure device | Other | Single arm study; all patients treated with an annular closure device Receives: Device: Annular closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Amount of blood loss measured in ml
Measured: Intra-operative
Procedure time
Length of surgery, measured in minutes
Measured: Intra-operative
Hospital stay
Length of the hospital stay measured in days between hospital admission and hospital discharge
Measured: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Discharge status
Evaluation of improvement in motor and sensory neurologic status
Measured: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Leg pain severity (0-100 VAS score)
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Measured: Baseline, 4 Weeks, 3 Months, 1 year
Back pain severity (0-100 VAS score)
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Measured: Baseline, 4 Weeks, 3 Months, 1 year
ODI
Change from baseline in Oswestry Disability Index. The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability
Measured: Baseline, 4 Weeks, 3 Months, 1 year
EQ-5D
Change from baseline in EQ-5D. The EuroQol (EQ-5D) is a generic utility measure used to characterize current health states. The subject-reported questionnaire consists of 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which can take one of three responses. Possible responses include three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension
Measured: Baseline, 4 Weeks, 3 Months, 1 year
Satisfaction with surgery procedure
Patient satisfaction with surgery and treatment assessed utilizing questionnaire with Composite questionnaire with 2 questions will be administered; 1.) Indicate degree of satisfaction with the outcome and 2.) likelihood of recommending the procedure to others
Measured: 1 year
Neurological assessment
Change from baseline in sensory (sensation response at dermatomal levels) reflex, (knee jerk, ankle jerk, response measured as "normal", "increased", "absent" and "decreased") and muscle strength measured 0-5 with "0" representing no evidence of motor strength and "5" representing full resistance
Measured: Baseline, 4 Weeks, 3 Months, 1 year
Adverse events
Change of health status with occurrence of adverse event, reported by seriousness and relationship to the device or procedure
Measured: Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
Hospital readmission occurrence
Change from baseline in incidence of re-admissions to hospital, post treatment
Measured: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Symptomatic reherniation incidence
Change from baseline in incidence of post-operative recurrent herniation at the index level. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review
Measured: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Reoperation incidence
Change from baseline in incidence of post-operative reoperation at the index level
Measured: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Return to work assessment
Change from baseline in work status (ability to return to work, with or without reported restrictions)
Measured: 4 Weeks, 3 Months, 1 year
Opioid consumption
Change from baseline for all opioid based medications (routes of administration (oral, IV, transdermal), dosing (mg/ml/tablet), duration (days)).
Measured: Baseline, Intra-operative, Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 May 2020
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intrinsic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David H Kim, MD, Study chair, New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986580
- Sponsor's protocol ID
- CP-010
- Status last verified
- Sep 2023
- First submitted
- 6 Jun 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Strenge KB, DiPaola CP, Miller LE, Hill CP, Whitmore RG. Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol. Medicine (Baltimore). 2019 Aug;98(35):e16953. doi: 10.1097/MD.0000000000016953.
PubMed 31464935
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Of Lumbar Discectomy With Additional Implantation Of An Annular Closure Device In Patients With Large Postsurgical Annular Defects For Prevention Of Lumbar Disc Reherniation
- ClinicalTrials.gov ID
- NCT03986580
- Acronym / sponsor ID
- CP-010
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Intrinsic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 May 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jun 2019 (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.
The purpose of this prospective, single-arm, multicenter study is to assess an annular closure device when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone.
Detailed description
This single-arm case series will enroll 75 patients at select US (approximately 8-10) sites. Patients that are scheduled for a single-level L4-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients that meet all intraoperative criteria will be enrolled into the study and treated with lumbar discectomy and additional annular closure device implantation. All enrolled subjects will be followed for at least 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Annular closure device | Other | Device: Annular closure deviceSingle arm study; all patients treated with an annular closure device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years old and skeletally mature (male or female)
- Subjects 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 anular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.]
- At least six (6) weeks of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.;
- 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)
Key exclusion criteria (30 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 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.
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 |
|---|---|---|
| Annular closure deviceAnnular closure, following limited discectomy procedure at a single LS level between L4 and S1 | Device | Annular closure device |
Primary outcome
Blood loss
Time frame: Intra-operative
Amount of blood loss measured in ml
Procedure time
Time frame: Intra-operative
Length of surgery, measured in minutes
Hospital stay
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Length of the hospital stay measured in days between hospital admission and hospital discharge
Discharge status
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery)
Evaluation of improvement in motor and sensory neurologic status
Leg pain severity (0-100 VAS score)
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
Back pain severity (0-100 VAS score)
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline of Visual Analogue Scale score (values between 0-100), with lower values representing better outcome
ODI
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline in Oswestry Disability Index. The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability
EQ-5D
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline in EQ-5D. The EuroQol (EQ-5D) is a generic utility measure used to characterize current health states. The subject-reported questionnaire consists of 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which can take one of three responses. Possible responses include three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension
Satisfaction with surgery procedure
Time frame: 1 year
Patient satisfaction with surgery and treatment assessed utilizing questionnaire with Composite questionnaire with 2 questions will be administered; 1.) Indicate degree of satisfaction with the outcome and 2.) likelihood of recommending the procedure to others
Neurological assessment
Time frame: Baseline, 4 Weeks, 3 Months, 1 year
Change from baseline in sensory (sensation response at dermatomal levels) reflex, (knee jerk, ankle jerk, response measured as "normal", "increased", "absent" and "decreased") and muscle strength measured 0-5 with "0" representing no evidence of motor strength and "5" representing full resistance
Adverse events
Time frame: Baseline, Intra-operative, 4 Weeks, 3 Months, 1 year
Change of health status with occurrence of adverse event, reported by seriousness and relationship to the device or procedure
Hospital readmission occurrence
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of re-admissions to hospital, post treatment
Symptomatic reherniation incidence
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of post-operative recurrent herniation at the index level. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review
Reoperation incidence
Time frame: Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline in incidence of post-operative reoperation at the index level
Return to work assessment
Time frame: 4 Weeks, 3 Months, 1 year
Change from baseline in work status (ability to return to work, with or without reported restrictions)
Opioid consumption
Time frame: Baseline, Intra-operative, Post-procedure hospital discharge day (in average between 1 and 3 days post surgery), 4 Weeks, 3 Months, 1 year
Change from baseline for all opioid based medications (routes of administration (oral, IV, transdermal), dosing (mg/ml/tablet), duration (days)).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 31464935Strenge KB, DiPaola CP, Miller LE, Hill CP, Whitmore RG. Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol. Medicine (Baltimore). 2019 Aug;98(35):e16953. doi: 10.1097/MD.0000000000016953.
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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. This study is not recruiting at the moment.
David H Kim, MD study chair
New England Baptist Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annular closure device in people with Lumbar Disc Herniation, run by Intrinsic Therapeutics at 7 sites 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 8 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: Intra-operative). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986580, which also lists 1 linked publication.
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 28 Sep 2023.