Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex

NCT05281757 | Recruiting

• 1 other identifier: AAG-O-H-2022
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief Summary

Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)

Conditions

Hyperkyphosis; Hyperlordosis; Congenital Scoliosis; Neuromuscular Scoliosis; Idiopathic Scoliosis

Keywords

upper-thoracic spine

Outcome Measures

Primary Outcomes (1)

• Change of Pain

  ain will be assessed by the patient using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal / worst pain".

  preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively

Secondary Outcomes (4)

• Change of Quality of Life

  preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively

• Change of Every day life

  preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively

• Bone Fusion

  at final follow-up approximately 24 months after surgery

• Cumulative number of Side effects

  throughout the follow-up up to 24 months postoperatively

Study Arms (1)

Ennovate® Complex

All patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU)

Device: posterior stabilization for the cervical spine

Interventions

posterior stabilization for the cervical spine DEVICE

The Ennovate® Complex Spinal System is a posterior stabilization for the Complex and upper-thoracic spine. The implants are used for the posterior multisegmental correction and stabilization over all sections of the spine.

Ennovate® Complex

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are treated with the Ennovate® Complex system system in accordance with the indications given in the instructions for use: Hyper- / hypokyphosis, Hyper- / hypolordosis, Scoliosis

You may qualify if:

• Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old
• Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18
• Patient's indication according to IFU
• Patient is not pregnant

You may not qualify if:

• Patient's clear unability or unwillingness to participate in follow-up examinations

Sponsors & Collaborators

• Aesculap AG: lead
• Raylytic GmbH: collaborator

Study Sites (2)

University Hospital Brno

Brno, 62500, Czechia

SUSPENDED

Hospital Universiti Kebangsaan Malaysia (HUKM)

Kuala Lumpur, Malaysia

RECRUITING

MeSH Terms

Conditions

Kyphosis; Swayback

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Sheep Diseases; Animal Diseases

Study Officials

• Mohd Hisam, Prof. Dr.

  Hospital Universiti Kebangsaan Malaysia (HUKM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Mattes

CONTACT

+497461950; sarah.mattes@aesculap.de

Stefan Maenz

CONTACT

+497461950; stefan.maenz@aesculap.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: February 18, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); MY (1)