Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Study

Lumbar Disc Herniation Clinical Trial

Official title:

Effectiveness of Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824108
• Other study ID #: WALLIS-2008
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2013
• Last updated: March 31, 2013
• Start date: July 2008
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Procedure:
• Lumbar discectomy
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 system
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.

Locations

Country	Name	City	State
China	Guangdong Gerneral Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) at 2 days before intervention	baseline VAS	2 days before intervention	No
Primary	Visual Analogue Scale (VAS) at 1 week after intervention		1 week after intervention	No
Primary	Visual Analogue Scale (VAS) at 12 months after intervention		12 months after intervention	No
Primary	Visual Analogue Scale (VAS) at 24 months after intervention		24 months after intervention	No
Primary	Japanese Orthopedics Association (JOA) at 2 days before intervention	baseline JOA	2 days before intervention	No
Primary	Japanese Orthopedics Association (JOA) at 1 week after intervention		1 week after intervention	No
Primary	Japanese Orthopedics Association (JOA) at 12 months after intervention		12 months after intervention	No
Primary	Japanese Orthopedics Association (JOA) at 24 months after intervention		24 months after intervention	No
Primary	Oswestry Disability Index (ODI) at 2 days before intervention	baseline ODI	2 days before intervention	No
Primary	Oswestry Disability Index (ODI) at 1 week after intervention		1 week after intervention	No
Primary	Oswestry Disability Index (ODI) at 12 months after intervention		12 months after intervention	No
Primary	Oswestry Disability Index (ODI) at 24 months after intervention		24 months after intervention	No
Secondary	Intervertebral disc height of the operated segments		2 days before intervention and 1 week, 12 months and 24 months after intervention	No
Secondary	Range of motion of the operated segments		2 days before intervention, 12 months and 24 months after intervention	No
Secondary	Complications	Complications: includes dural laceration, implant loose, lumbar kyphosis, spinous process fracture or recurrent lumbar disc herniation	1 week, 12 months and 24 months after intervention	Yes