Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ennovate® Cervical, open surgical technique
DevicePatients 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
DevicePatients 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Implantation Ennovate® Cervical system using an open surgical techniqueActive comparator 1 intervention
Group B: Implantation Ennovate® Cervical system using a minimally invasive technique.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogue Scale (VAS)
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.
Time frame
4 (+/- 1 day) postoperativeSecondary outcomes
1
Screw placement accuracy
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.
Time frame
intraoperative or discharge visit (approx. 10 days post op.)2
Neck Disability Index (NDI)
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
Time frame
praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)3
Quality of Life (EQ-5D-5L)
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".
Time frame
praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)4
Quality of Life (EQ-VAS)
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".
Time frame
praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)Sponsors and contacts
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Source ClinicalTrials.gov