Minimally invasive Ennovate® method for cervical pedicle screw placement
Controlled, Randomized Clinical Study to Demonstrate the Patient Benefit and Safety of Pedicle Screw Placement Through an Innovative Minimally Invasive Surgical Approach Using the Ennovate® Cervical Spinal System
This project tests whether the minimally invasive Ennovate® method for placing cervical pedicle screws is safe and helps adults who need posterior cervical fusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 3 sites (Aachen and 2 other locations) |
| Trial ID | NCT06960018 on ClinicalTrials.gov |
What this trial studies
The study collects clinical data comparing a minimally invasive Ennovate® cervical pedicle screw technique to the standard open surgical approach for posterior cervical fusion. Adult patients (age ≥18) receiving Ennovate® Cervical internal fixation between C2 and Th3 will be enrolled and followed for safety, implant stability, and recovery outcomes. Surgeons will use either the minimally invasive or open technique with the Ennovate® Cervical Spinal System and outcomes will include complication rates, radiographic stability, and patient-centered measures such as pain and return to function. Routine postoperative follow-up visits will capture clinical and device-related data to inform benefit and risk profiles.
Who should consider this trial
Good fit: Adults 18 or older scheduled to receive Ennovate® Cervical internal fixation between C2 and Th3 for restoration and stabilization of the cervical spine who can provide consent and attend routine follow-up are ideal candidates.
Not a fit: Patients with severe bone disorders (for example severe osteoporosis or Paget's disease), active vertebral infection, suspected allergy to implant materials, or those unable to comply with follow-up are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the minimally invasive approach could reduce tissue damage, shorten hospital stays, and speed recovery while maintaining spinal stability.
How similar studies have performed: Minimally invasive pedicle screw techniques elsewhere in the spine have shown reduced blood loss and faster recovery, but minimally invasive cervical pedicle fixation with the Ennovate® method is relatively novel and has limited published clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Aachen and 2 other locations
- Universitätsklinikum Aachen — Aachen, Germany (Recruiting)
- Charité Berlin — Berlin, Germany (Recruiting)
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany (Recruiting)
Study contacts
- Study coordinator: Sarah Mattes
- Email: studies@aesculap.de
- Phone: +497461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.