Degenarative diseases
Conditions
Interventions
NA All interventies are standard conform the hospital protocol for this sort of
patients.
Sponsors
mediqol
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •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.
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint, percent reduction in the Oswestry Disability Score (at six months relative to pre-treatment), will be analysed using both a paired t-test and the non-parametric Wi1coxon signed¬rank test. | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary endpoints (see Section 3.4) will be analysed using appropriate descriptive statistical techniques and where possible, paired or repeated measures statistical analyses will be conducted in order to examine the Oswestry Disability Index, the SF-36, the Visual Analogue Scale, and patient satisfaction over time (baseline, 6 weeks, 3 months, 12 months). | — |
Countries
Netherlands
Outcome results
None listed