A pilot study to evaluate the Safety and Performance of the Percutaneuos Dynamic Stabilization (PDS) system for the treatment of mild to Moderate Degenerative Disc disease
- Conditions
- Degenarative diseases10005944
- Registration Number
- NL-OMON30202
- Lead Sponsor
- mediqol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
•Patients aged between 18 and 60 years of age inclusive.
•Patients with evidence of mild to moderate degenerative disc disease at a single level of the lumbar spine (L 1 through to SI) confirmed by MRI within the last 6 months.
•Patients with clinical evidence of degenerative disc disease experiencing back pain and confirmed by provocative discography at the target level.
•Patients who have failed to adequately improve following a 3 month period of conservative management, who in the opinion of the Clinical Investigator, require surgical intervention or aggressive conservative management.
•Patients who have a minimum baseline Oswestry Score of30% (15/50).
•Patients who are able to give voluntary, \vritten informed consent to participate in this study and from whom consent has been obtained.
•Patients, who, in the opinion of the Clinical Investigator, are able to understand this study, co-operate with the procedures and are willing to return to the hospital for all the required post-operatiw follOw'-up procedures.
•Patients who, in the opinion of the Clinical Investigator, haw 2.would compromise their participation and follow-up in this study.
•Patients who have rheumatoid arthritis, lupus, osteoporosis (T<1.0) disease, osteomalacia, Paget's disease, other metabolic bone disease : syndrome.
•Patients who have significant spondylosis, scoliosis, kyphosis or any oc~-condition which would compromise their participation.
•Patients with evidence of tumour and/or malignant disease with resultant life expectancy of less than one year.
•Patients who are immunocompromised or being treated with immunosuppressive agents.
and/or present with a significant general illness that decreases the probability of surviyal.
•Patients who have leg pain without back pain ..
•Patients with greater than 50% disc collapse as compared to adjacent discs.
•Patients with Modic 2 or Modic 3 bone changes at the target level.
•Patients with radiographic confirmation of severe facet joint disease or degeneration.
•Patients with clinically compromised vertebral bodies at the affected level due to current
or past trauma like sustained pathological fracture or multiple fractures of vertebrae.
•Patients with evidence of an active systemic infection or an infection at the target level.
•Patients with a known allergy to titanium and/or polycarbonate urethane (PCD).
•Subjects with concomitant conditions requiring steroid treatment or prior steroid usage within the last 3 months.
•Patients who have previously had spine surgery performed at the target level or an adjacent level.
•Patients who have previously participated in any experimental spinal implant or treatment.
•Patients who have any injury litigation claims pending.
•Patients who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint, percent reduction in the Oswestry Disability Score (at<br /><br>six months relative to pre-treatment), will be analysed using both a paired<br /><br>t-test and the non-parametric Wi1coxon signed¬rank test. </p><br>
- Secondary Outcome Measures
Name Time Method <p> All secondary endpoints (see Section 3.4) will be analysed using appropriate<br /><br>descriptive statistical techniques and where possible, paired or repeated<br /><br>measures statistical analyses will be conducted in order to examine the<br /><br>Oswestry Disability Index, the SF-36, the Visual Analogue Scale, and patient<br /><br>satisfaction over time (baseline, 6 weeks, 3 months, 12 months). </p><br>