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NCT Number: NCT06960018

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

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.

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Key information

Conditions

Cervical Spine Disease Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ennovate® Cervical, open surgical technique

Device

Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of

  • Fractures
  • Degenerative instability
  • Post-trauma instability
  • Tumors
  • Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using an open surgical technique

Ennovate® Cervical, minimal invasive surgical technique

Device

Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of

  • Fractures
  • Degenerative instability
  • Post-trauma instability
  • Tumors
  • Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using a minimally invasive technique.

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 4 (+/- 1 day) postoperative

    Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.

Secondary outcomes

  1. Screw placement accuracy

    Time frame: intraoperative or discharge visit (approx. 10 days post op.)

    Evaluation of the accuracy of screw placement will be performed according to the method described by Bredow using CT/3D-Scans made at intraoperative/discharge visit.

  2. Neck Disability Index (NDI)

    Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)

    The Neck Disability Index (NDI) is a widely used and validated self-assessment tool for measuring disability due to neck pain. (Measured over the course of the study)

    • 0-4 (0-8%): No disability
    • 5-14 (10-28%): Mild disability
    • 15-24 (30-48%): Moderate disability
    • 25-34 (50-64%): Severe disability
    • 35-50 (70-100%): Complete disability

  3. Quality of Life (EQ-5D-5L)

    Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)

    EQ-5D is a standardized 5-dimension (5D) 5-level (5L) measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".

  4. Quality of Life (EQ-VAS)

    Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)

    EQ-5D is a standardized 5-dimension (5D) 5-level (5L) measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".

  5. Rate of Adverse Events / Serious Adverse Events

    Time frame: During the course of the study up to two years postoperatively

    (Serious) Adverse Events During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects ((S)AE) related or not related to the product under investigation, will be documented. The total number of (S)AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product.

  6. Visual Analogue Scale (VAS)

    Time frame: praeoperative, postoperative (2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)

    Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Mattes

CONTACT

[email protected]

+497461

Stefan Maenz, Dr.

CONTACT

[email protected]

+497461

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: MISPEC

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 7, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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