Clinical trial NCT05281757: Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Official title: Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperkyphosis
Hyperlordosis
Congenital Scoliosis
Neuromuscular Scoliosis
Idiopathic Scoliosis
Keywords: upper-thoracic spine
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Raylytic GmbH
First posted: 2022-03-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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)

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change of Pain
timeFrame: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
Secondary outcomes:
measure: Change of Quality of Life
timeFrame: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
measure: Change of Every day life
timeFrame: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
measure: Bone Fusion
timeFrame: at final follow-up approximately 24 months after surgery
measure: Cumulative number of Side effects
timeFrame: throughout the follow-up up to 24 months postoperatively
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
city: Kuala Lumpur
country: Malaysia
facility: Hospital Universiti Kebangsaan Malaysia (HUKM)
Study officials:
affiliation: Hospital Universiti Kebangsaan Malaysia (HUKM)
name: Mohd Hisam, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: