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

NCT01824108 | Completed Phase 3

• 1 other identifier: WALLIS-2008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

Lumbar disc herniation; Wallis interspinous implants; lumbar discectomy; interspinous dynamic stability system

Outcome Measures

Primary Outcomes (12)

• Visual Analogue Scale (VAS) at 2 days before intervention

  baseline VAS

  2 days before intervention

• 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

  baseline JOA

  2 days before intervention

• 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

  baseline ODI

  2 days before intervention

• 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 Outcomes (3)

• 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

Study Arms (2)

control group: Lumbar discectomy

ACTIVE COMPARATOR

Lumbar discectomy alone

Procedure: Lumbar discectomy

Treatment group: lumbar discectomy + Wallis implant

EXPERIMENTAL

lumbar discectomy combined with Wallis interspinous dynamic stability system

Procedure: Lumbar discectomy combined with Wallis interspinous dynamic stability system

Interventions

Lumbar discectomy PROCEDURE

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.

control group: Lumbar discectomy

Lumbar discectomy combined with Wallis interspinous dynamic stability system PROCEDURE

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.

Treatment group: lumbar discectomy + Wallis implant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• previous operations;
• congenital spinal deformity;
• lumbar fracture;
• infection;
• autoimmune diseases;
• serious osteoporosis;
• morbidly obese;

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Gerneral Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopaedic Surgery

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 4, 2013
• Study Start: July 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2013-03

Locations

CN (1)