Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement (MISPEC)

Aesculap

Status

Enrolling

Conditions

Pain, Postoperative

Cervical Spine Disease

Treatments

Device: Ennovate® Cervical, minimal invasive surgical technique

Device: Ennovate® Cervical, open surgical technique

Study type

Interventional

Funder types

Industry

Identifiers

NCT06960018

AAG-O-H-23045

Details and patient eligibility

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.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.