Status:
COMPLETED
Wallis Interspinous Dynamic Stability System for Lumbar Disc Herniation: a Prospective Study
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Lumbar Disc Herniation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 superi...
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...
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01824108
Start Date
July 1 2008
End Date
October 1 2012
Last Update
April 4 2013
Active Locations (1)
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1
Guangdong Gerneral Hospital
Guangzhou, Guangdong, China, 510080