Lumbar Spine Disc HerniationNCT02477176
Lumbar Discectomy Control Study, Risk Factors for Reherniation
An observational study of Lumbar Spine Disc Herniation, run by Intrinsic Therapeutics at 4 sites in United States.
Trial summary
The purpose of this 12-month, prospective, multicenter study is to investigate the effect of annular defect size and other risk factors on reherniation and associated costs in primary lumbar discectomy patients. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Lumbar Spine Disc Herniation
- What is being tested?
- Discectomy
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Feb 2016to Mar 2025
- Phase
- Observational
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with single level, symptomatic lumbar disc herniation
Who may be able to join
- Age 21 to 75 years old and skeletally mature (male or female).
- Patients with posterior or posterolateral disc herniations at one level between L1 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.]
- Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1) or Femoral Stretch Test (L12, L23, L34)
- 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.
- Minimum posterior disc height of 5mm at the index level.
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 dual energy x-ray absorptiometry (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 27Show 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 equine 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).
- Subject has been diagnosed with active hepatitis, AIDS, or HIV.
- Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
- 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.
- Subject is currently involved in another investigational study.
- Subject is incarcerated.
- Patients will be divided into two arms (small- and large-defect) based on the width of their annular defect as measured intra-operatively. Patients with defects <6mm in width will be in the "small defect" arm; patients with defects ≥6mm in width will be in the "large defect" arm. Each arm will be capped at 50 patients. Once 50 patients are accrued in one arm, subsequent patients who meet the criteria for that arm will be excluded. Enrollment will continue until both arms are filled.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Midwest Orthopaedics at Rush Medical Center
Chicago, Illinois, 60612
Michigan Orthopedic Specialists
Dearborn, Michigan, 48124
Orthopaedic Specialists Of The Four States
Galena, Kansas, 66739
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
About this study
Official title: A Prospective, Multicenter Study Investigating Reherniation Risk Factors and Associated Costs in Primary Lumbar Disc Herniation Patients
The purpose of this 12-month, prospective, multicenter study is to investigate the effect of annular defect size and other risk factors on reherniation and associated costs in primary lumbar discectomy patients.
Read the detailed description
This study will enroll up to 100 patients at select US (approximately 4-7) sites. Patients that are scheduled for an L1-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients will be divided into two arms (small- and large-defect) based on the size of their annular defect as measured intra-operatively; each arm will be capped at 50 patients. All patients included in the trial will be followed for at least 12 months.
- Conditions
- Lumbar Spine Disc Herniation
- Being tested
- Discectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscectomyOther
Lumbar discectomy
| Study group | Role | What they receive |
|---|---|---|
| Small annular defect group | Patients with lumbar defect less than 6mm wide after lumbar discectomy Receives: Other: Discectomy | |
| Large annular defect group | Patients with lumbar defect greater than 6mm wide after lumbar discectomy Receives: Other: Discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar reherniation at the index level
Reherniation of index level, yes or no
Measured: 12 Months
Secondary outcomes (2)
Reoperation at the index level
Reoperation at index level, yes or no
Measured: 12 Months
Hospitalization at physician cost
The total hospitalization and physician costs for the index surgery and any secondary surgical intervention of the index level will be summed and reported for each subject based on data collected on the UB-04
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study start17 Feb 2016
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 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, New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477176
- Sponsor's protocol ID
- US CONTROL-001
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2015
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- A Prospective, Multicenter Study Investigating Reherniation Risk Factors and Associated Costs in Primary Lumbar Disc Herniation Patients
- ClinicalTrials.gov ID
- NCT02477176
- Acronym / sponsor ID
- US CONTROL-001
- Conditions
- Lumbar Spine Disc Herniation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Intrinsic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Jun 2015 (estimated)
- 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 12-month, prospective, multicenter study is to investigate the effect of annular defect size and other risk factors on reherniation and associated costs in primary lumbar discectomy patients.
Detailed description
This study will enroll up to 100 patients at select US (approximately 4-7) sites. Patients that are scheduled for an L1-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients will be divided into two arms (small- and large-defect) based on the size of their annular defect as measured intra-operatively; each arm will be capped at 50 patients. All patients included in the trial will be followed for at least 12 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small annular defect group | – | Other: DiscectomyPatients with lumbar defect less than 6mm wide after lumbar discectomy |
| Large annular defect group | – | Other: DiscectomyPatients with lumbar defect greater than 6mm wide after lumbar discectomy |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with single level, symptomatic lumbar disc herniation
Key inclusion criteria (7 listed)
- Age 21 to 75 years old and skeletally mature (male or female).
- Patients with posterior or posterolateral disc herniations at one level between L1 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.]
- Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1) or Femoral Stretch Test (L12, L23, L34)
- Oswestry Questionnaire score of at least 40/100 at baseline.
- VAS leg pain (one or both legs) of at least 40/100 at baseline.
Key exclusion criteria (27 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 dual energy x-ray absorptiometry (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 |
|---|---|---|
| DiscectomyLumbar discectomy | Other | Large annular defect group, Small annular defect group |
Primary outcome
Lumbar reherniation at the index level
Time frame: 12 Months
Reherniation of index level, yes or no
2 secondary outcomes
Reoperation at the index level
Time frame: 12 Months
Hospitalization at physician cost
Time frame: 12 Months
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.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Disc Herniation, run by Intrinsic Therapeutics at 4 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 7 inclusion and 27 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 4 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?
Lumbar reherniation at the index level (time frame: 12 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 28 Sep 2023.