Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Study
- Conditions
- Lumbar Disc Herniation
- Interventions
- Procedure: Lumbar discectomyProcedure: Lumbar discectomy combined with Wallis interspinous dynamic stability system
- Registration Number
- NCT01824108
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group: Lumbar discectomy Lumbar discectomy Lumbar discectomy alone Treatment group: lumbar discectomy + Wallis implant Lumbar discectomy combined with Wallis interspinous dynamic stability system lumbar discectomy combined with Wallis interspinous dynamic stability system
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) at 2 days before intervention 2 days before intervention baseline VAS
Visual Analogue Scale (VAS) at 1 week after intervention 1 week after intervention Visual Analogue Scale (VAS) at 12 months after intervention 12 months after intervention Visual Analogue Scale (VAS) at 24 months after intervention 24 months after intervention Japanese Orthopedics Association (JOA) at 2 days before intervention 2 days before intervention baseline JOA
Japanese Orthopedics Association (JOA) at 1 week after intervention 1 week after intervention Japanese Orthopedics Association (JOA) at 12 months after intervention 12 months after intervention Japanese Orthopedics Association (JOA) at 24 months after intervention 24 months after intervention Oswestry Disability Index (ODI) at 2 days before intervention 2 days before intervention baseline ODI
Oswestry Disability Index (ODI) at 1 week after intervention 1 week after intervention Oswestry Disability Index (ODI) at 12 months after intervention 12 months after intervention Oswestry Disability Index (ODI) at 24 months after intervention 24 months after intervention
- Secondary Outcome Measures
Name Time Method Intervertebral disc height of the operated segments 2 days before intervention and 1 week, 12 months and 24 months after intervention Range of motion of the operated segments 2 days before intervention, 12 months and 24 months after intervention Complications 1 week, 12 months and 24 months after intervention Complications: includes dural laceration, implant loose, lumbar kyphosis, spinous process fracture or recurrent lumbar disc herniation
Trial Locations
- Locations (1)
Guangdong Gerneral Hospital
🇨🇳Guangzhou, Guangdong, China