Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy
Stopped: The clinical trial was terminated prematurely due to receipt of CE mark
Paraguay9 participantsStarted 2019-09-19
Plain-language summary
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
Who can participate
Age range21 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is skeletally mature and between 21 and 60 years of age.
* Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1
* History and clinical findings suggestive of symptomatic DDD:
Darkened disc on MRI in T2 weighted images Patients with at least 6 months of low back pain (location defined as the space between the lower margin of the posterior rib cage and horizontal gluteal fold) that is resistant to nonsurgical conservative therapy.
* Patient has adequate disc height (\~6mm) at the level to be treated
* Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale).
* Patient has pre-operative back pain VAS score of greater than or equal to 40 (0-100 scale)
* Patient has received conservative, non-surgical treatment for back pain for a minimum of 6 months.
* Patient has signed the approved Informed Consent Form.
Exclusion Criteria:
* Patient has had prior lumbar spine surgery
* Spinal fusion at any level
* Patient has ankylosing spondylitis or other spondyloarthropathy.
* Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
* Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
* Patient has significant facet disease.
* Patient has had prior lumbar spine surgery
* Spinal fusion at any level
* Patient has any known active malignancy.
* Patient has previously undergone or currently on immunosuppressive thera…
What they're measuring
1
Post surgical change in degree of disability
Timeframe: 6 months
2
Post surgical change in back pain: Visual Analogue Scale