M42.12 M47.22 M48 M50.0 M50.1 M50.2 M54.12 M54.19
Conditions
Interventions
Group 1: Patients with chronic pain in the cervical area and/or in the arm area get an Oyster Cage implanted. The Neck Disability Index (NDI) assesses the impairment for these patients preoperative co
Sponsors
Silony Medical GmbH, Clinical Affairs
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria Skeletally mature patients with one of the following indications: + Degenerative disc disease (DDD) + Prolapsed intervertebral disc and symptomatic cervical + Spondylosis + Spondylotic myelopathy and foraminal stenosis + Spine trauma, lesions and revision surgeries + Willingly sign informed consent.
Exclusion criteria
Exclusion criteria: Based on the contra-indications for the device, the following exclusion criteria apply: + Spondylosis + Overweight (BMI > 40) + Implantation in patients with an active infection or pronounced local inflammation in the area of surgery + Severe osteoporosis affecting the spine + Primary or metastatic tumors affecting the spine + Suspected allergy or foreign body reaction to titanium or titanium alloys + Patients whose ability to follow postoperative restrictions, precautions and rehabilitation programs is limited + Fractures, severe deformities or an instability in the area of surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome measured with the Neck Disability Index (NDI) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess device-related complications of the Oyster® cage, including the + prevalence of revision surgery, + unanticipated complications or + serious adverse device effects or rare events To assess pain relief To assess device performance in terms of restoration of height and cervical lordosis | — |
Countries
Germany
Contacts
Public ContactJana Wilke
Klinik für Spinale Chirurgie, Schön Klinik Holding SE
Outcome results
None listed