M19.05 M99.84
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients male and female aged> 18 years; Previous conservative treatment with insufficient success; Positive results after intra-articular injections of local anesthetics; Positive decision on the surgical intervention by the treating doctor and by the patient
Exclusion criteria
Exclusion criteria: Manifest osteoporosis; Women of childbearing age without adequate contraceptive protection; Pregnant women; Contraindication to anesthesia; Immature patients or patients with insufficient compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patient's opinion regarding their satisfaction with the treatment result 6 months after the Surgery in comparison for both iFuse implants. | — |
Secondary
| Measure | Time frame |
|---|---|
| pain severity (VAS) follow-up examinations after 6 weeks, after 6 months and additionally for the closed cases after 12, 24 and 36 months; functional ability (Oswestry Score) to the above times; patients`s opinion on the above times | — |
Countries
Germany
Contacts
Paracelsus-Klinik Schöneck Wirbelsäulenchirurgie/ Neurotraumatologie