Clinical trial NCT01824108: Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Study
Official title: Effectiveness of Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbar Disc Herniation
Keywords: Lumbar disc herniation
Wallis interspinous implants
lumbar discectomy
interspinous dynamic stability system
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. 18-70 years old;
2. complaining low back pain or radioactive melosalgia;
3. preoperative image examination showing disc herniation or spinal stenosis caused by herniation of responsible level;
4. no improvement in symptoms after 6-10 weeks of non-surgical treatment.

Exclusion criteria:

1. previous operations;
2. congenital spinal deformity;
3. lumbar fracture;
4. infection;
5. autoimmune diseases;
6. serious osteoporosis;
7. morbidly obese;

Primary outcomes:
measure: Visual Analogue Scale (VAS) at 2 days before intervention
timeFrame: 2 days before intervention
measure: Visual Analogue Scale (VAS) at 1 week after intervention
timeFrame: 1 week after intervention
measure: Visual Analogue Scale (VAS) at 12 months after intervention
timeFrame: 12 months after intervention
measure: Visual Analogue Scale (VAS) at 24 months after intervention
timeFrame: 24 months after intervention
measure: Japanese Orthopedics Association (JOA) at 2 days before intervention
timeFrame: 2 days before intervention
measure: Japanese Orthopedics Association (JOA) at 1 week after intervention
timeFrame: 1 week after intervention
measure: Japanese Orthopedics Association (JOA) at 12 months after intervention
timeFrame: 12 months after intervention
measure: Japanese Orthopedics Association (JOA) at 24 months after intervention
timeFrame: 24 months after intervention
measure: Oswestry Disability Index (ODI) at 2 days before intervention
timeFrame: 2 days before intervention
measure: Oswestry Disability Index (ODI) at 1 week after intervention
timeFrame: 1 week after intervention
measure: Oswestry Disability Index (ODI) at 12 months after intervention
timeFrame: 12 months after intervention
measure: Oswestry Disability Index (ODI) at 24 months after intervention
timeFrame: 24 months after intervention
Secondary outcomes:
measure: Intervertebral disc height of the operated segments
timeFrame: 2 days before intervention and 1 week, 12 months and 24 months after intervention
measure: Range of motion of the operated segments
timeFrame: 2 days before intervention, 12 months and 24 months after intervention
measure: Complications
timeFrame: 1 week, 12 months and 24 months after intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Gerneral Hospital
state: Guangdong
Study officials:
References: