Status:
RECRUITING
Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
Lead Sponsor:
Aesculap AG
Conditions:
Cervical Spine Disease
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sta...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Absolute contraindications according to the IFU:
- 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.
- Acute or chronic vertebral infections of a local or systemic nature.
- Poor patient compliance or limited ability to follow medical instructions, particularly in the postop phase, including with regard to the restrictions on range of movement in terms of physical exercise and occupational activity.
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06960018
Start Date
June 20 2025
End Date
November 1 2028
Last Update
June 26 2025
Active Locations (3)
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1
Universitätsklinikum Aachen
Aachen, Germany, 52074
2
Charité Berlin
Berlin, Germany, 10117
3
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 70196