Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation Ennovate® Cervical system using an open surgical technique | Active Comparator |
| |
| Implantation Ennovate® Cervical system using a minimally invasive technique. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ennovate® Cervical, open surgical technique | Device | Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 (+/- 1 day) postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperative or discharge visit (approx. 10 days post op.) |
| Neck Disability Index (NDI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Absolute contraindications according to the IFU:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Mattes | Contact | +497461 | 0 | studies@aesculap.de |
| Stefan Maenz, Dr. | Contact | +497461 | 0 | studies@aesculap.de |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Aachen | Recruiting | Aachen | 52074 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Block randomization with random block length will be used. The electronic data capture system will instruct the clinical investigator to use either the open or the minimally invasive 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
|
|
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)
|
| praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years) |
| 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". | praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years) |
| 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". | praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years) |
| Rate of Adverse Events / Serious Adverse Events | (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. | During the course of the study up to two years postoperatively |
| 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. | praeoperative, postoperative (2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years) |
| Charité Berlin | Recruiting | Berlin | 10117 | Germany |
|
| Universitätsklinikum Freiburg | Recruiting | Freiburg im Breisgau | 70196 | Germany |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided