CERVICAL DEGENERATIV EDISC DISEASE
Conditions
Interventions
Group 1: Patients requiring an anterior cervical discectomy and fusion (ACDF) procedure and who are suitable to receive the Medacta Mecta-C Stand Alone implant
Sponsors
Medacta Internaional
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Both genders • Older than 18 years • Degenerative disk disease at minimum one level from C2 to T1 and with at least six weeks of non-operative treatment • Patients requiring ACDF procedures according to manufacturer’s IFU • Patients willing and able to sign the written informed consent
Exclusion criteria
Exclusion criteria: • Physical conditions that could delay healing or impair the implant’s success according to manufacturer’s IFU • Patients’ inability, in the opinion of the investigator, to comply with the study schedule • Patients with malignant diseases (at the time of surgery) • Patients with proven or suspected infections (at the time of surgery) • Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the percentage of success in getting bone fusion at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess clinical and functional outcomes. To assess neck and arm pain. To assess radiological outcomes (optional). To evaluate device-related complications. | — |
Countries
Austria, Germany
Contacts
Public ContactElisa Bonacina
Medacta International
Outcome results
None listed