Clinical trial NCT06960018: Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Spine Disease
Pain, Postoperative
Keywords: posterior cervical fusion
pedicle screw
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly allocated to one of the two study groups in a 1:1 ratio.

In addition, stratification by clinical investigation sites is applied. Group 1: Patients treated with the Ennovate® Cervical system using an open surgical technique. Group 2: Patients treated with the Ennovate® Cervical system using a minimally invasive technique. Study is designed to provide a comparison of the both groups regarding the short-term pain outcome.
Primary purpose: TREATMENT

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 state of the art open surgical approach using the Ennovate® Cervical Spinal System.


Eligibility 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 4 (+/- 1 day) postoperative
Secondary outcomes:
measure: Screw placement accuracy
timeFrame: intraoperative or discharge visit (approx. 10 days post op.)
measure: Neck Disability Index (NDI)
timeFrame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
measure: Quality of Life (EQ-5D-5L)
timeFrame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
measure: Quality of Life (EQ-VAS)
timeFrame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
measure: Rate of Adverse Events / Serious Adverse Events
timeFrame: During the course of the study up to two years postoperatively
measure: Visual Analogue Scale (VAS)
timeFrame: praeoperative, postoperative (2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Other outcomes:
Locations:
Study officials:
References: