NCT05281757

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

Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Detailed description

This clinical study is one of the Post-Market Clinical Follow-Up (PMCF) measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Complex system. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in deformity disorders.

Conditions

• Hyperkyphosis
• Hyperlordosis
• Congenital Scoliosis
• Neuromuscular Scoliosis
• Idiopathic Scoliosis

Interventions

Type	Name	Description
DEVICE	posterior stabilization for the cervical spine	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.

Timeline

• Start date: 2022-02-18
• Primary completion: 2026-04-01
• Completion: 2028-10-01
• First posted: 2022-03-16
• Last updated: 2026-04-15

Locations

2 sites across 2 countries: Czechia, Malaysia