Actively Recruiting
Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
Led by Aesculap AG · Updated on 2026-04-15
76
Participants Needed
3
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Patients receiving Ennovate4 Cervical internal fixation device from vertebrae C2 to Th3
- Patients needing restoration and stabilization of the cervical spine
You will not qualify if you...
- Patients unwilling to sign consent
- Patients unable to attend routine follow-up visits
- Severe bone damage preventing stable implant placement (e.g., osteopenia, severe osteoporosis, Paget's disease, bone tumors)
- Metabolic or degenerative bone diseases affecting implant stability
- Suspected allergy or sensitivity to implant materials
- Acute or chronic vertebral infections
- Poor compliance or inability to follow medical instructions, especially postoperatively
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universitätsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
2
Charité Berlin
Berlin, Germany, 10117
Actively Recruiting
3
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 70196
Actively Recruiting
Research Team
S
Sarah Mattes
CONTACT
S
Stefan Maenz, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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