Chronic Low Back Pain Clinical Trial
— DISCERNOfficial title:
Debilitating Low Back paIn: Multi-centre Safety and performanCe invEstigation Of CAdiscTM-L, Total Disc ReplacemeNt Therapy
The purpose of this European Union (EU) study to evaluate the safety and performance of the CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients requiring surgical intervention for total lumbar disc replacement for the treatment of debilitating, chronic low back pain.
Status | Completed |
Enrollment | 0 |
Est. completion date | June 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or non pregnant, non-lactating female - Aged between 25-65 years (inclusive) - BMI < 35 - Preoperative ODI > 30 points - Chronic low back pain, and is in the opinion of the investigator a suitable candidate for anterior lumbar surgery - Completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief - Degenerative disc changes at a single level between L3 - L4, or L4 - L5, or L5 - S1 as confirmed by positive discography and visualized by X-Ray, CT or MRI scan and/or with one or more of the following: - Decrease in disc height < 50% (or up to 80% and no benefit from facet injections) - Annular thickening - Herniated nucleus pulpous - Subject is able to give voluntary, written informed consent to participate in this investigation and from whom written consent must be obtained prior to enrolment. Exclusion Criteria: - Back or leg pain of unknown aetiology - Radicular or sciatic pain which is more severe than low back pain - Previous lumbar spinal surgery which could affect the trial outcome (e.g., disc replacement) - Obvious signs of psychological or worker's compensation or litigation claim elements to their condition, or are actively engaged in such activities - Subject is unwilling or unable to give consent or adhere to the follow-up programme - Active infection or metastatic disease - Non-degenerative spondylolisthesis - Degenerative spondylolisthesis > grade 1 - Known allergy to any of the implant materials - Osteoporosis (if suspected to be confirmed by bone density being 2.5SD below normal as assessed using DEXA analysis in post-menopausal females if suggested by X-ray or other risk factors) - Osteopenia - Bony lumbar stenosis - Pars defect - Isolated radicular compression syndromes, especially due to disc herniation - Clinically compromised vertebral bodies at the affected levels due to current or past trauma - Subject is skeletally immature as determined by the investigator - Subject has participated in another clinical investigation or study with an investigational medical device within the last 60 days - Concomitant medications that are known significantly to interfere with bone/soft tissue healing, e.g. steroids. - Uncorrected iliac, aorto-iliac, or aortic aneurysm disease. - Spinal instability (> 3mm translation or > 5° angulation) confirmed by functional radiological assessment. - Degenerative disc changes at the L6 - S1 level |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ranier Technology Limited |
Belgium, Germany, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03243084 -
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
|
N/A | |
Suspended |
NCT04735185 -
Stem Cells vs. Steroids for Discogenic Back Pain
|
N/A | |
Completed |
NCT03162952 -
RAND Center of Excellence for the Study of Appropriateness of Care in CAM
|
||
Completed |
NCT03240146 -
Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain
|
N/A | |
Completed |
NCT05282589 -
Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients
|
N/A | |
Completed |
NCT03637998 -
Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT02289170 -
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
|
N/A | |
Active, not recruiting |
NCT01944163 -
The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain
|
N/A | |
Completed |
NCT02231554 -
Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT02063503 -
Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients
|
N/A | |
Terminated |
NCT01620775 -
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
|
N/A | |
Completed |
NCT01704677 -
Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
|
N/A | |
Completed |
NCT01177241 -
Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
|
N/A | |
Completed |
NCT01490905 -
A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain
|
Phase 4 | |
Completed |
NCT01177254 -
Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions
|
N/A | |
Completed |
NCT01177280 -
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes
|
N/A | |
Completed |
NCT00984815 -
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
|
Phase 3 | |
Completed |
NCT00763321 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 | |
Completed |
NCT00761150 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 | |
Completed |
NCT00767806 -
A Study for Patient With Chronic Low Back Pain
|
Phase 3 |