Lumbar Disc HerniationPhase 3NCT01824108
Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Study
A Phase 3 study testing Lumbar discectomy and Lumbar discectomy combined with Wallis interspinous dynamic stability system in people with Lumbar Disc Herniation, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Lumbar disc herniation is usually treated by discectomy alone. Nonfusion system such as Wallis interspinous implants have also been successfully used in disc degenerative diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Lumbar discectomy and Lumbar discectomy combined with Wallis interspinous dynamic stability system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Oct 2012
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old;
- complaining low back pain or radioactive melosalgia;
- preoperative image examination showing disc herniation or spinal stenosis caused by herniation of responsible level;
- no improvement in symptoms after 6-10 weeks of non-surgical treatment.
Who cannot join
- previous operations;
- congenital spinal deformity;
- lumbar fracture;
- infection;
- autoimmune diseases;
- serious osteoporosis;
- morbidly obese;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Randomised Controlled Study
Lumbar disc herniation is usually treated by discectomy alone. Nonfusion system such as Wallis interspinous implants have also been successfully used in disc degenerative diseases. However, the superiority of a discectomy with Wallis in comparison to a discectomy alone for primary lumbar disc herniation has yet to be determined.The aim of our study is to investigate whether lumbar discectomy combined with the Wallis device provides better radiographic and clinical short-term outcome than posterior lumbar discectomy alone.
Read the detailed description
The most commonly used therapy for lumbar disc herniation (LDH) are partial discectomy or discectomy with fusion if there was an additional mechanical disorder in the underlying functional spinal unit. However, the problems associated with discectomy are intervertebral disc height loss and the segmental instability, thought to be a risk for failed back surgery syndrome or recurrence lumbar disc herniation. Fusion has also been criticised for its side effects of adjacent segment degeneration(ASD), pseudarthrosis and bone-graft morbidity. To prevent such complications , a new family of dynamic implants have been established. Wallis interspinous implant (Abbott Laboratories, Bordeaux, France) , invented by J. Senegas, is one of them. It consisted of a interspinous blocker made out of polyetheretherketone (PEEK) to limit extension and two dacron tapes around the spinous processes in order to secure the implant and limit flexion. The aim of using this device is to unload the facet joints, to restore foraminal height and to provide sufficient stability especially in extension but still allow motion in the treated segment. Previous clinical trials and biomechanical studies are promising, however, the superiority of a discectomy with Wallis in comparison to a discectomy alone for primary lumbar disc herniation has yet to be determined. The purpose of this prospective controlled study was to evaluate the clinical effect of lumbar discectomy combined with Wallis interspinous device, comparing with posterior lumbar discectomy alone. Our hypothesis was that the use of the Wallis device would have better clinical and radiological outcomes than lumbar discectomy alone.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Lumbar discectomy, Lumbar discectomy combined with Wallis interspinous dynamic stability system
- Keywords
- Lumbar disc herniation, Wallis interspinous implants, lumbar discectomy, interspinous dynamic stability system
- 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.
Lumbar discectomyProcedure or surgery
All the patients were in prone positions on the operation table and received general anesthesia. A midline incision was made and paravertebral muscles were dissected unilaterally. Disc excision and nerve root decompression were initially accomplished through a unilateral transflaval approach. Then the wound was closed with a suction drain.
Lumbar discectomy combined with Wallis interspinous dynamic stability systemProcedure or surgery
The Wallis interspinous implant is placed after a lumbar discectomy. Interspinal ligaments of operated segment were removed and supraspinal ligament were retained. And then the proper size of Wallis implant was mounted underneath the supraspinous ligament and secured to the spine with the attached Dacron bands,above and below the corresponding spinous processes.
| Study group | Role | What they receive |
|---|---|---|
| control group: Lumbar discectomy | Active comparator | Lumbar discectomy alone Receives: Procedure: Lumbar discectomy |
| Treatment group: lumbar discectomy + Wallis implant | Experimental | lumbar discectomy combined with Wallis interspinous dynamic stability system Receives: Procedure: Lumbar discectomy combined with Wallis interspinous dynamic stability system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) at 2 days before intervention
baseline VAS
Measured: 2 days before intervention
Visual Analogue Scale (VAS) at 1 week after intervention
Measured: 1 week after intervention
Visual Analogue Scale (VAS) at 12 months after intervention
Measured: 12 months after intervention
Visual Analogue Scale (VAS) at 24 months after intervention
Measured: 24 months after intervention
Japanese Orthopedics Association (JOA) at 2 days before intervention
baseline JOA
Measured: 2 days before intervention
Japanese Orthopedics Association (JOA) at 1 week after intervention
Measured: 1 week after intervention
Japanese Orthopedics Association (JOA) at 12 months after intervention
Measured: 12 months after intervention
Japanese Orthopedics Association (JOA) at 24 months after intervention
Measured: 24 months after intervention
Oswestry Disability Index (ODI) at 2 days before intervention
baseline ODI
Measured: 2 days before intervention
Oswestry Disability Index (ODI) at 1 week after intervention
Measured: 1 week after intervention
Oswestry Disability Index (ODI) at 12 months after intervention
Measured: 12 months after intervention
Oswestry Disability Index (ODI) at 24 months after intervention
Measured: 24 months after intervention
Secondary outcomes (3)
Intervertebral disc height of the operated segments
Measured: 2 days before intervention and 1 week, 12 months and 24 months after intervention
Range of motion of the operated segments
Measured: 2 days before intervention, 12 months and 24 months after intervention
Complications
Complications: includes dural laceration, implant loose, lumbar kyphosis, spinous process fracture or recurrent lumbar disc herniation
Measured: 1 week, 12 months and 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJul 2008
- Primary completionOct 2012
- Study completionOct 2012
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiujiang Zheng, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824108
- Sponsor's protocol ID
- WALLIS-2008
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01824108
- Acronym / sponsor ID
- WALLIS-2008
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar disc herniation, Wallis interspinous implants, lumbar discectomy, interspinous dynamic stability system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Apr 2013 (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.
Lumbar disc herniation is usually treated by discectomy alone. Nonfusion system such as Wallis interspinous implants have also been successfully used in disc degenerative diseases. However, the superiority of a discectomy with Wallis in comparison to a discectomy alone for primary lumbar disc herniation has yet to be determined.The aim of our study is to investigate whether lumbar discectomy combined with the Wallis device provides better radiographic and clinical short-term outcome than posterior lumbar discectomy alone.
Detailed description
The most commonly used therapy for lumbar disc herniation (LDH) are partial discectomy or discectomy with fusion if there was an additional mechanical disorder in the underlying functional spinal unit. However, the problems associated with discectomy are intervertebral disc height loss and the segmental instability, thought to be a risk for failed back surgery syndrome or recurrence lumbar disc herniation. Fusion has also been criticised for its side effects of adjacent segment degeneration(ASD), pseudarthrosis and bone-graft morbidity. To prevent such complications , a new family of dynamic implants have been established. Wallis interspinous implant (Abbott Laboratories, Bordeaux, France) , invented by J. Senegas, is one of them. It consisted of a interspinous blocker made out of polyetheretherketone (PEEK) to limit extension and two dacron tapes around the spinous processes in order to secure the implant and limit flexion. The aim of using this device is to unload the facet joints, to restore foraminal height and to provide sufficient stability especially in extension but still allow motion in the treated segment. Previous clinical trials and biomechanical studies are promising, however, the superiority of a discectomy with Wallis in comparison to a discectomy alone for primary lumbar disc herniation has yet to be determined. The purpose of this prospective controlled study was to evaluate the clinical effect of lumbar discectomy combined with Wallis interspinous device, comparing with posterior lumbar discectomy alone. Our hypothesis was that the use of the Wallis device would have better clinical and radiological outcomes than lumbar discectomy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group: Lumbar discectomy | Active comparator | Procedure: Lumbar discectomyLumbar discectomy alone |
| Treatment group: lumbar discectomy + Wallis implant | Experimental | Procedure: Lumbar discectomy combined with Wallis interspinous dynamic stability systemlumbar discectomy combined with Wallis interspinous dynamic stability system |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-70 years old;
- complaining low back pain or radioactive melosalgia;
- preoperative image examination showing disc herniation or spinal stenosis caused by herniation of responsible level;
- no improvement in symptoms after 6-10 weeks of non-surgical treatment.
Key exclusion criteria (7 listed)
- previous operations;
- congenital spinal deformity;
- lumbar fracture;
- infection;
- autoimmune diseases;
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 |
|---|---|---|
| Lumbar discectomyAll the patients were in prone positions on the operation table and received general anesthesia. A midline incision was made and paravertebral muscles were dissected unilaterally. Disc excision and nerve root decompression were initially accomplished through a unilateral transflaval approach. Then the wound was closed with a suction drain. | Procedure or surgery | control group: Lumbar discectomy |
| Lumbar discectomy combined with Wallis interspinous dynamic stability systemThe Wallis interspinous implant is placed after a lumbar discectomy. Interspinal ligaments of operated segment were removed and supraspinal ligament were retained. And then the proper size of Wallis implant was mounted underneath the supraspinous ligament and secured to the spine with the attached Dacron bands,above and below the corresponding spinous processes. | Procedure or surgery | Treatment group: lumbar discectomy + Wallis implant |
Primary outcome
Visual Analogue Scale (VAS) at 2 days before intervention
Time frame: 2 days before intervention
baseline VAS
Visual Analogue Scale (VAS) at 1 week after intervention
Time frame: 1 week after intervention
Visual Analogue Scale (VAS) at 12 months after intervention
Time frame: 12 months after intervention
Visual Analogue Scale (VAS) at 24 months after intervention
Time frame: 24 months after intervention
Japanese Orthopedics Association (JOA) at 2 days before intervention
Time frame: 2 days before intervention
baseline JOA
Japanese Orthopedics Association (JOA) at 1 week after intervention
Time frame: 1 week after intervention
Japanese Orthopedics Association (JOA) at 12 months after intervention
Time frame: 12 months after intervention
Japanese Orthopedics Association (JOA) at 24 months after intervention
Time frame: 24 months after intervention
Oswestry Disability Index (ODI) at 2 days before intervention
Time frame: 2 days before intervention
baseline ODI
Oswestry Disability Index (ODI) at 1 week after intervention
Time frame: 1 week after intervention
Oswestry Disability Index (ODI) at 12 months after intervention
Time frame: 12 months after intervention
Oswestry Disability Index (ODI) at 24 months after intervention
Time frame: 24 months after intervention
3 secondary outcomes
Intervertebral disc height of the operated segments
Time frame: 2 days before intervention and 1 week, 12 months and 24 months after intervention
Range of motion of the operated segments
Time frame: 2 days before intervention, 12 months and 24 months after intervention
Complications
Time frame: 1 week, 12 months and 24 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumbar discectomy and Lumbar discectomy combined with Wallis interspinous dynamic stability system in people with Lumbar Disc Herniation, run by Guangdong Provincial People's Hospital 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 7 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: finished, as of the sponsor's last update on 4 Apr 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale (VAS) at 2 days before intervention (time frame: 2 days before intervention). The study lists 12 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 4 Apr 2013; AzTrials last refreshed its copy on 30 Oct 2026.