Lumbar Disc HerniationNCT03359564
Microendoscopic Lumbar Discectomy: A Study of 100 Cases
An observational study of Lumbar Disc Herniation, run by Peking University People's Hospital.
Trial summary
Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- micro endoscopic discectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent surgery for herniated disc using the tubular retractor
Who may be able to join
- Patients with at least 6 weeks of conservative treatment with positive nerve root tension signs, radicular pain
- Patients are diagnosed with lumbar disc herniation by MRI
- Patients who underwent surgery for herniated disc using the tubular retractor
Who cannot join
- Patients with large central disc herniation, chronic discogenic pain, discitis, multi-level disease, presence of instability or history of lumbar surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microendoscopic Lumbar Discectomy: A Prospective Study of 100 Cases
Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.
Read the detailed description
Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.Patients who underwent surgery for herniated disc using the tubular retractors. The results were evaluated by using VAS (Visual Analog Scale 0-5) for back and leg pain and ODI (Oswestry Disability Index). Patients were followed up at intervals of 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years after surgery.
- Conditions
- Lumbar Disc Herniation
- Being tested
- micro endoscopic discectomy
- Keywords
- Lumbar Disc Herniation, Micro Endoscopic Discectomy
- 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.
micro endoscopic discectomyProcedure or surgery
the patients receive micro endoscopic discectomy surgery therapy
| Study group | Role | What they receive |
|---|---|---|
| micro endoscopic discectomy | the patients with lumbar disc herniation Receives: Procedure: micro endoscopic discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
The efficacy of surgery were evaluated by using Oswestry Disability Index.
Measured: 2 years after operation
Secondary outcomes (2)
Oswestry Disability Index
The efficacy of surgery were evaluated by using Oswestry Disability Index.
Measured: preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months after operation
Visual Analog Scale
The efficacy of surgery were evaluated by using Visual Analog Scale for back and leg pain.
Measured: preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, guochen, Peking University People's Hospital
- Investigators
- GUO chen, bachelor, Principal investigator, department of spinal surgery,PekingUPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359564
- Sponsor's protocol ID
- MED007
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microendoscopic Lumbar Discectomy: A Prospective Study of 100 Cases
- ClinicalTrials.gov ID
- NCT03359564
- Acronym / sponsor ID
- MED007
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar Disc Herniation, Micro Endoscopic Discectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Dec 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.
Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.
Detailed description
Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.Patients who underwent surgery for herniated disc using the tubular retractors. The results were evaluated by using VAS (Visual Analog Scale 0-5) for back and leg pain and ODI (Oswestry Disability Index). Patients were followed up at intervals of 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro endoscopic discectomy | – | Procedure: micro endoscopic discectomythe patients with lumbar disc herniation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery for herniated disc using the tubular retractor
Key inclusion criteria (3 listed)
- Patients with at least 6 weeks of conservative treatment with positive nerve root tension signs, radicular pain
- Patients are diagnosed with lumbar disc herniation by MRI
- Patients who underwent surgery for herniated disc using the tubular retractor
Key exclusion criteria (1 listed)
- Patients with large central disc herniation, chronic discogenic pain, discitis, multi-level disease, presence of instability or history of lumbar surgery
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 |
|---|---|---|
| micro endoscopic discectomythe patients receive micro endoscopic discectomy surgery therapy | Procedure or surgery | micro endoscopic discectomy |
Primary outcome
Oswestry Disability Index
Time frame: 2 years after operation
The efficacy of surgery were evaluated by using Oswestry Disability Index.
2 secondary outcomes
Oswestry Disability Index
Time frame: preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months after operation
Visual Analog Scale
Time frame: preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperative follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
GUO chen, bachelor principal investigator
department of spinal surgery,PekingUPH
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation, run by Peking University People's Hospital.
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 3 inclusion and 1 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact YU Guanjie, bachelor (18500234005, yuguanjieok@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: 2 years after operation). 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 2 Dec 2017.