Actively Recruiting
Multicenter Post Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex System in Scoliosis Patients
Led by Aesculap AG · Updated on 2026-06-02
200
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
A
Aesculap AG
Lead Sponsor
R
Raylytic GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on monitoring the safety and performance of the Ennovate® Complex spinal system in patients with scoliosis and related spine deformities such as hyperkyphosis, hyperlordosis, congenital scoliosis, and neuromuscular scoliosis. It is a multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study designed to collect detailed data on the use of this implant system as part of routine clinical practice without any intervention by the study team. The Ennovate® Complex system is a device used for posterior stabilization and correction across multiple segments of the cervical and upper-thoracic spine. All patients treated with this system according to the official instructions for use are included in the study. The study involves prospective data collection that documents clinical and radiological outcomes related to this implant. Participants will be followed over approximately two years after surgery, with assessments before surgery and at multiple intervals postoperatively (3-4 months, 12 months, and 24 months). Researchers will track changes in pain, quality of life, daily functioning, and bone fusion as well as any side effects throughout the follow-up period. This extensive documentation aims to provide valuable information on the implant's safety and performance for current and future patients.
CONDITIONS
Brief Title
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who provide informed consent
- Patients under 18 years who provide informed consent along with their legal representative (parent)
- Patient's treatment indication follows the instructions for use of the Ennovate® Complex system
- Patient is not pregnant
You will not qualify if you...
- Patient is clearly unable or unwilling to participate in follow-up examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Short-term around the surgery date
Participants undergo surgery with the Ennovate® Complex system for posterior stabilization of the spine and receive immediate post-operative care.
1 baseline visit (preoperative) and 1 visit shortly after surgery (in-person)
Duration - Up to 24 months after surgery
Participants are monitored for safety and performance of the implant including assessments of pain, quality of life, daily activities, and bone fusion.
Visits at 3-4 months, approximately 12 months, and approximately 24 months postoperatively
Trial Site Locations
Total: 2 locations
1
University Hospital Brno
Brno, Czechia, 62500
Suspended
2
Hospital Universiti Kebangsaan Malaysia (HUKM)
Kuala Lumpur, Malaysia
Actively Recruiting
Research Team
S
Sarah Mattes
S
Stefan Maenz
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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