Minimally invasive Ennovate® method for cervical pedicle screw placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.