Lumbar Disc HerniationUSLSINCT03252691
Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
An observational study of Lumbar Disc Herniation and Anular Tear of Lumbar Disc, run by Intrinsic Therapeutics at 1 site in United States.
Trial summary
Lumbar discectomy study, collection and evaluation of incidence of large annular defects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation, Anular Tear of Lumbar Disc, Nucleus Pulp Hernia;Lumbosac
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2020to 18 May 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred and fifty (150) subjects will participate in the study. Participants will be between 18 and 75 years of age. All subjects will have been diagnosed with primary lumbar disc herniation requiring surgical discectomy as per the opinion of the treating surgeon. All subjects who meet the inclusion criteria, do not meet any of the exclusion criteria, and who elect to participate and sign the informed consent will be included in the study.
Who may be able to join
- Must be 18-75 years of age, and skeletally mature
- Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1.
- Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care.
- Subject must understand and sign the written Informed Consent.
Who cannot join
- Prior surgery at the index lumbar vertebral level.
- Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain
- Morbid obesity (BMI ≥ 40 kg/m2)
- Investigational drug or device use within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients
Lumbar discectomy study, collection and evaluation of incidence of large annular defects.
Read the detailed description
This study is designed as a single-site prospective data collection. Measurements will be collected during 150 consecutive standard of care primary lumbar discectomy procedures.
- Medical subject headings
- Intervertebral Disc Displacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of large defects noted on primary lumbar discectomy procedure.
Annular defect size will be measured intra-operatively.
Measured: Intra-operatively
Secondary outcomes (2)
Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.
Amount of nucleus removed will be measured intra-operatively.
Measured: Intra-operatively
Verify access to annular defect with approved manual surgical instruments.
Access to the annular defect will be evaluated intra-operatively.
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startSep 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completion18 May 2021
Why it stopped: Site closure and no patient enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intrinsic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reginald Davis, MD, Principal investigator, Laser Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252691
- Sponsor's protocol ID
- USCONTROL-USLSI-001
- Acronym
- USLSI
- Status last verified
- May 2021
- First submitted
- 15 Aug 2017
- Last updated
- 20 May 2021
- 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 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients
- ClinicalTrials.gov ID
- NCT03252691
- Acronym / sponsor ID
- USLSI / USCONTROL-USLSI-001
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Site closure and no patient enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Intrinsic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- 18 May 2021 (actual)
- First posted
- 17 Aug 2017 (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.
Lumbar discectomy study, collection and evaluation of incidence of large annular defects.
Detailed description
This study is designed as a single-site prospective data collection. Measurements will be collected during 150 consecutive standard of care primary lumbar discectomy procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and fifty (150) subjects will participate in the study. Participants will be between 18 and 75 years of age. All subjects will have been diagnosed with primary lumbar disc herniation requiring surgical discectomy as per the opinion of the treating surgeon. All subjects who meet the inclusion criteria, do not meet any of the exclusion criteria, and who elect to participate and sign the informed consent will be included in the study.
Key inclusion criteria (4 listed)
- Must be 18-75 years of age, and skeletally mature
- Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1.
- Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care.
- Subject must understand and sign the written Informed Consent.
Key exclusion criteria (4 listed)
- Prior surgery at the index lumbar vertebral level.
- Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain
- Morbid obesity (BMI ≥ 40 kg/m2)
- Investigational drug or device use within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of large defects noted on primary lumbar discectomy procedure.
Time frame: Intra-operatively
Annular defect size will be measured intra-operatively.
2 secondary outcomes
Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.
Time frame: Intra-operatively
Verify access to annular defect with approved manual surgical instruments.
Time frame: Intra-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
Related trials for Lumbar Disc Herniation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
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.
Reginald Davis, MD principal investigator
Laser Spine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Anular Tear of Lumbar Disc, 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 May 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of large defects noted on primary lumbar discectomy procedure. (time frame: Intra-operatively). 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 20 May 2021.