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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Completed; Phase 3

Conditions: Lumbar Disc Herniation

Treatments: Procedure: Lumbar discectomy combined with Wallis interspinous dynamic stability system; Procedure: Lumbar discectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01824108

WALLIS-2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

control group: Lumbar discectomy

Active Comparator group

Description:

Lumbar discectomy alone

Treatment:

Procedure: Lumbar discectomy

Treatment group: lumbar discectomy + Wallis implant

Experimental group

Description:

lumbar discectomy combined with Wallis interspinous dynamic stability system

Treatment:

Procedure: Lumbar discectomy combined with Wallis interspinous dynamic stability system