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

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lumbar discectomy
Lumbar discectomy combined with Wallis interspinous dynamic stability system
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar disc herniation, Wallis interspinous implants, lumbar discectomy, interspinous dynamic stability system

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Guangdong Gerneral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group: Lumbar discectomy

Treatment group: lumbar discectomy + Wallis implant

Arm Description

Lumbar discectomy alone

lumbar discectomy combined with Wallis interspinous dynamic stability system

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS) at 2 days before intervention
baseline VAS
Visual Analogue Scale (VAS) at 1 week after intervention
Visual Analogue Scale (VAS) at 12 months after intervention
Visual Analogue Scale (VAS) at 24 months after intervention
Japanese Orthopedics Association (JOA) at 2 days before intervention
baseline JOA
Japanese Orthopedics Association (JOA) at 1 week after intervention
Japanese Orthopedics Association (JOA) at 12 months after intervention
Japanese Orthopedics Association (JOA) at 24 months after intervention
Oswestry Disability Index (ODI) at 2 days before intervention
baseline ODI
Oswestry Disability Index (ODI) at 1 week after intervention
Oswestry Disability Index (ODI) at 12 months after intervention
Oswestry Disability Index (ODI) at 24 months after intervention

Secondary Outcome Measures

Intervertebral disc height of the operated segments
Range of motion of the operated segments
Complications
Complications: includes dural laceration, implant loose, lumbar kyphosis, spinous process fracture or recurrent lumbar disc herniation

Full Information

First Posted
March 25, 2013
Last Updated
March 31, 2013
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01824108
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar disc herniation, Wallis interspinous implants, lumbar discectomy, interspinous dynamic stability system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group: Lumbar discectomy
Arm Type
Active Comparator
Arm Description
Lumbar discectomy alone
Arm Title
Treatment group: lumbar discectomy + Wallis implant
Arm Type
Experimental
Arm Description
lumbar discectomy combined with Wallis interspinous dynamic stability system
Intervention Type
Procedure
Intervention Name(s)
Lumbar discectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lumbar discectomy combined with Wallis interspinous dynamic stability system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) at 2 days before intervention
Description
baseline VAS
Time Frame
2 days before intervention
Title
Visual Analogue Scale (VAS) at 1 week after intervention
Time Frame
1 week after intervention
Title
Visual Analogue Scale (VAS) at 12 months after intervention
Time Frame
12 months after intervention
Title
Visual Analogue Scale (VAS) at 24 months after intervention
Time Frame
24 months after intervention
Title
Japanese Orthopedics Association (JOA) at 2 days before intervention
Description
baseline JOA
Time Frame
2 days before intervention
Title
Japanese Orthopedics Association (JOA) at 1 week after intervention
Time Frame
1 week after intervention
Title
Japanese Orthopedics Association (JOA) at 12 months after intervention
Time Frame
12 months after intervention
Title
Japanese Orthopedics Association (JOA) at 24 months after intervention
Time Frame
24 months after intervention
Title
Oswestry Disability Index (ODI) at 2 days before intervention
Description
baseline ODI
Time Frame
2 days before intervention
Title
Oswestry Disability Index (ODI) at 1 week after intervention
Time Frame
1 week after intervention
Title
Oswestry Disability Index (ODI) at 12 months after intervention
Time Frame
12 months after intervention
Title
Oswestry Disability Index (ODI) at 24 months after intervention
Time Frame
24 months after intervention
Secondary Outcome Measure Information:
Title
Intervertebral disc height of the operated segments
Time Frame
2 days before intervention and 1 week, 12 months and 24 months after intervention
Title
Range of motion of the operated segments
Time Frame
2 days before intervention, 12 months and 24 months after intervention
Title
Complications
Description
Complications: includes dural laceration, implant loose, lumbar kyphosis, spinous process fracture or recurrent lumbar disc herniation
Time Frame
1 week, 12 months and 24 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: previous operations; congenital spinal deformity; lumbar fracture; infection; autoimmune diseases; serious osteoporosis; morbidly obese;
Facility Information:
Facility Name
Guangdong Gerneral Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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

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