Menu
Recruiting NCT06960018

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

No phase Interventional Cervical Spine Disease Pain, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ennovate® Cervical, open surgical technique, Ennovate® Cervical, minimal invasive surgical technique.
Who it may be relevant to
Registry conditions: Cervical Spine Disease, Pain, Postoperative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device Ennovate® Cervical, open surgical technique
    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
  • Device Ennovate® Cervical, minimal invasive surgical technique
    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 outcome measures

  • Visual Analogue Scale (VAS) [Time frame: 4 (+/- 1 day) postoperative]
Secondary outcome measures (6)
  • Screw placement accuracy [Time frame: intraoperative or discharge visit (approx. 10 days post op.)]
  • Neck Disability Index (NDI) [Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)]
  • 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)]
  • Quality of Life (EQ-VAS) [Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)]
  • Rate of Adverse Events / Serious Adverse Events [Time frame: During the course of the study up to two years postoperatively]
  • Visual Analogue Scale (VAS) [Time frame: praeoperative, postoperative (2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 3 centers
  • Universitätsklinikum Aachen — Aachen
  • Charité Berlin — Berlin
  • Universitätsklinikum Freiburg — Freiburg im Breisgau

Identifiers

NCT: NCT06960018 · AAG-O-H-23045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗