Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the Ennovate® Cervical Spinal System.
Eligibility criteria
Qualifiers
All patients with minimum 18 years of age receiving Ennovate® Cervical internal fixation device within the vertebral bodies C2-Th3 to ensure the restoration and stabilization of the cervical spine
Disqualifiers
All patients not willing to sign the patient consent are excluded. Also, if it is clear from the beginning, that the patient will not be able to come to routine follow-up, the patient will also be excluded.
Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia, severe osteoporosis, Paget's disease, bone tumors etc.
Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system.
Suspected allergy or sensitivity to the implant materials.
Trial design
Treatments tested in this trial
- Ennovate® Cervical, open surgical technique
- Ennovate® Cervical, minimal invasive surgical technique
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov