Herniated DiscPhase 4NCT01204008
Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy
A Phase 4 study testing conservative discectomy and aggressive discectomy in people with Herniated Disc, run by Sun Yat-sen University at 1 site in China.
Trial summary
Summary: This is a prospective randomize study to compare conservative and aggressive discectomy for treatment of disc herniation with radiculopathy. Study hypothesis: The investigators believe that conservative discectomy could preserve a higher disc space and has a better long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Herniated Disc
- What is being tested?
- conservative discectomy and aggressive discectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Dec 2015
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Duration of symptoms: 6 or more weeks.
- Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
- Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
- Tests: MRI to confirm diagnosis and level(s).
Who cannot join
- Previous lumbar spine surgery.
- Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
- Possible pregnancy.
- Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years.
- Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
- Age less than 18 years.
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- Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery).
- Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.
- Symptoms less than 6 weeks.
- Patient currently enrolled in any experimental "spine related" study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen memorial hospital
Guangzhou, Guangdong, 510120
Dongsheng Huang, MD, 00862081332553, huangdongshen18@hotmail.com
Dongsheng Huang, MD
About this study
Official title: A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
Summary: This is a prospective randomize study to compare conservative and aggressive discectomy for treatment of disc herniation with radiculopathy.
Study hypothesis: The investigators believe that conservative discectomy could preserve a higher disc space and has a better long-term outcomes.
Read the detailed description
objectives:to compare the effect of two type surgery(conservative discectomy and aggressive discectomy)on disc herniation with radiculopathy after long-term follow-up.
methods:the patients who were confirmed suffer from disc herniation with radiculopathy and failed to nonsurgical treatment will be divided into two groups, and will be follow up 3~6 years for seeking the effect on disc space preservation and recurrent.
outcome measures:the rate of pain release and patients satisfaction were measured by SF-36,ODI,VAS,score post-OP. the height of disc was measured on X-ray film by the end point.
- Conditions
- Herniated Disc
- Being tested
- conservative discectomy, aggressive 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.
conservative discectomyProcedure or surgery
a smaller incision with removal of the disc fragment with little invasion of the disc
aggressive discectomyProcedure or surgery
a large open incision with aggressive removal of the disc fragments and curettage of the disc space
| Study group | Role | What they receive |
|---|---|---|
| CS | Experimental | conservative discectomy Receives: Procedure: conservative discectomy |
| AS | Active comparator | Not described Receives: Procedure: aggressive discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients satisfaction
Measured: 6 weeks after intervention
patients satisfaction
Measured: 3 months after intervention
patients satisfaction
Measured: 6 months after intervention
patients satisfaction
Measured: 1st year after intervention
patients satisfaction
Measured: 3rd year after intervention
patients satisfaction
Measured: 5th year after intervention
Secondary outcomes (12)
recurrence rate of disc herniation
Measured: 6 weeks after operation
recurrence rate of disc herniation
Measured: 3 months after operation
recurrence rate of disc herniation
Measured: 6 months after operation
recurrence rate of disc herniation
Measured: 1st year after operation
recurrence rate of disc herniation
Measured: 3rd year after operation
recurrence rate of disc herniation
Measured: 5th year after operation
height of disc space
Measured: 6 weeks after operation
height of disc space
Measured: 3 months after operation
height of disc space
Measured: 6 months after operation
height of disc operation
Measured: 1st year after operation
height of disc space
Measured: 3rd year after operation
height of disc space
Measured: 5th year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiscStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Dongsheng Huang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204008
- Sponsor's protocol ID
- zseyhds2
- Status last verified
- Aug 2007
- First submitted
- 13 Sep 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trails for Primary Disc Herniation With Radiculopathy:Conservative Versus Aggressive Discectomy
- ClinicalTrials.gov ID
- NCT01204008
- Acronym / sponsor ID
- zseyhds2
- Conditions
- Herniated Disc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Sep 2010 (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.
Summary: This is a prospective randomize study to compare conservative and aggressive discectomy for treatment of disc herniation with radiculopathy.
Study hypothesis: The investigators believe that conservative discectomy could preserve a higher disc space and has a better long-term outcomes.
Detailed description
objectives:to compare the effect of two type surgery(conservative discectomy and aggressive discectomy)on disc herniation with radiculopathy after long-term follow-up.
methods:the patients who were confirmed suffer from disc herniation with radiculopathy and failed to nonsurgical treatment will be divided into two groups, and will be follow up 3~6 years for seeking the effect on disc space preservation and recurrent.
outcome measures:the rate of pain release and patients satisfaction were measured by SF-36,ODI,VAS,score post-OP. the height of disc was measured on X-ray film by the end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS | Experimental | Procedure: conservative discectomyconservative discectomy |
| AS | Active comparator | Procedure: aggressive discectomy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Duration of symptoms: 6 or more weeks.
- Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
- Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
- Tests: MRI to confirm diagnosis and level(s).
Key exclusion criteria (10 listed)
- Previous lumbar spine surgery.
- Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
- Possible pregnancy.
- Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years.
- Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
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 |
|---|---|---|
| conservative discectomya smaller incision with removal of the disc fragment with little invasion of the disc | Procedure or surgery | CS |
| aggressive discectomya large open incision with aggressive removal of the disc fragments and curettage of the disc space | Procedure or surgery | AS |
Primary outcome
patients satisfaction
Time frame: 6 weeks after intervention
patients satisfaction
Time frame: 3 months after intervention
patients satisfaction
Time frame: 6 months after intervention
patients satisfaction
Time frame: 1st year after intervention
patients satisfaction
Time frame: 3rd year after intervention
patients satisfaction
Time frame: 5th year after intervention
12 secondary outcomes
recurrence rate of disc herniation
Time frame: 6 weeks after operation
recurrence rate of disc herniation
Time frame: 3 months after operation
recurrence rate of disc herniation
Time frame: 6 months after operation
recurrence rate of disc herniation
Time frame: 1st year after operation
recurrence rate of disc herniation
Time frame: 3rd year after operation
recurrence rate of disc herniation
Time frame: 5th year after operation
height of disc space
Time frame: 6 weeks after operation
height of disc space
Time frame: 3 months after operation
height of disc space
Time frame: 6 months after operation
height of disc operation
Time frame: 1st year after operation
height of disc space
Time frame: 3rd year after operation
height of disc space
Time frame: 5th year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
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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.
Dongsheng Huang, MD principal investigator
Sun Yat-sen University
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 conservative discectomy and aggressive discectomy in people with Herniated Disc, run by Sun Yat-sen University at 1 site in China.
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 10 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 17 Sep 2010. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongsheng Huang, MD. (00862081332553, huangdongshen18@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients satisfaction (time frame: 6 weeks after intervention). The study lists 6 primary outcomes in all. 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 17 Sep 2010.