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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2028-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Concurrent Treatment for Patients With Cervical Radiculopathy

NCT03636009

Spinal Nerve Root Disorder Nos

UNKNOWN NA

Analysis of Sub Axial Cervical Pedicle Spine Based on CT

NCT06445348

Cervical Pedicle Screw

NOT_YET_RECRUITING

In Vivo Quantification of Cervical Collar Efficacy

NCT05262140

Spine Injury

RECRUITING

Accuracy And Safety of Trans Pedicular Screw Fixation of The Sub-axial Cervical Spine Using A Triad- Dependent Technique

NCT05855642

Pedicle Screw CPS

UNKNOWN

Manual Therapy and Movement Control Exercises for Chronic Neck Pain. A Pilot Randomized Controlled Trial

NCT06189612

Neck Pain Temporomandibular Disorder

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Spine Disease Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Implantation Ennovate® Cervical system using an open surgical technique

Group Type ACTIVE_COMPARATOR

Ennovate® Cervical, open surgical technique

Intervention Type 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

Implantation Ennovate® Cervical system using a minimally invasive technique.

Group Type EXPERIMENTAL

Ennovate® Cervical, minimal invasive surgical technique

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No