HyperkyphosisCOSINENCT05281757
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
An observational study of Hyperkyphosis and Hyperlordosis, run by Aesculap AG at 2 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperkyphosis, Hyperlordosis, Congenital Scoliosis
- What is being tested?
- posterior stabilization for the cervical spine
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Feb 2022to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient's clear unability or unwillingness to participate in follow-up examinations
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Universiti Kebangsaan Malaysia (HUKM)
Kuala Lumpur
Mohd Hisam, Prof. Dr.
About this study
Official title: Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients
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)
Read the 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
- Being tested
- posterior stabilization for the cervical spine
- Keywords
- upper-thoracic spine
- Medical subject headings
- Kyphosis, Swayback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior stabilization for the cervical spineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ennovate® Complex | All patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU) Receives: Device: posterior stabilization for the cervical spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
Secondary outcomes (4)
Change of Quality of Life
In order to analyze the quality of life of the patients, the most current questionnaire of the Scoliosis Research Society (SRS), the "SRS-30" is used. The SRS-30 demonstrates how spinal conditions impact quality of life and facilitate comparisons of the quality of life before and after surgical intervention. It is widely used in the evaluation of the treatment of idiopathic scoliosis patients. SRS-30 is a patient self administered questionnaire and has a minimum score of 30 and a maximum score of 150 including postsurgery questions. Each question is scored on 1-5 scale. Questions are sorted into different domains and total and mean scores for each domain are calculated. A total score for the entire questionnaire is also calculated.
Measured: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
Change of Every day life
Clinical Results measured by Oswestry Disability Index (ODI). ODI contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0 (indicating the least amount of disability) to 5 5 (indicating most severe disability). The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
Bone Fusion
After Complex stabilization fusion of the treated segment is aspired in most cases. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.
Measured: at final follow-up approximately 24 months after surgery
Cumulative number of Side effects
Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications Adverse Events and Serious Adverse Events deemed related to the investigational device are recorded.
Measured: throughout the follow-up up to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start18 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Responsible party
- Sponsor
- Investigators
- Mohd Hisam, Prof. Dr., Principal investigator, Hospital Universiti Kebangsaan Malaysia (HUKM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281757
- Sponsor's protocol ID
- AAG-O-H-2022
- Acronym
- COSINE
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients
- ClinicalTrials.gov ID
- NCT05281757
- Acronym / sponsor ID
- COSINE / AAG-O-H-2022
- Conditions
- Hyperkyphosis, Hyperlordosis, Congenital Scoliosis, Neuromuscular Scoliosis, Idiopathic Scoliosis
- Keywords
- upper-thoracic spine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ennovate® Complex | – | Device: posterior stabilization for the cervical spineAll patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient's clear unability or unwillingness to participate in follow-up examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior stabilization for the cervical spineThe 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. | Device | Ennovate® Complex |
Primary outcome
Change of Pain
Time frame: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
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".
4 secondary outcomes
Change of Quality of Life
Time frame: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
Change of Every day life
Time frame: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively
Bone Fusion
Time frame: at final follow-up approximately 24 months after surgery
Cumulative number of Side effects
Time frame: throughout the follow-up up to 24 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Hyperkyphosis
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
Enrolling by invitation
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Hyperkyphosis, Adolescent
Not yet recruiting
Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
Hyperkyphosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Kinesio Taping in Young Adults With Thoracic Hyperkyphosis
Thoracic Hyperkyphosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohd Hisam, Prof. Dr. principal investigator
Hospital Universiti Kebangsaan Malaysia (HUKM)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkyphosis and Hyperlordosis, run by Aesculap AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Mattes (+497461950, sarah.mattes@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain (time frame: preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.