Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration (NCT07259811) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration
Germany10 participantsStarted 2023-09-18
Plain-language summary
This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and works well in early testings, so that a larger safety study can be done later to help get CE approval. The VCFix Spinal System will be used in its independent setup, within its planned use for treatment of vertebral compression fracture. It's designed to be a small early study to test safety and see if the treatment idea is possible, with one group and no blinding. Two hospitals in EU will enroll in total 10 participants with a single vertebral fracture that will undergo the same surgery.
The main test goals are: how successful the access creation of the vertebral body is using the VCFix Preparation kit according to the provided instructions, how successful the positioning of the VCFix implant is by using the VCFix Implantation kit according to the provided instructions, and how successful the fracture reduction by expanding the VCFix implant according to the provided instructions. The main safety goal is: number of device-/procedure-related major side effects through 30 days after the initial procedure.
Participant enrollment will last around 12 months. Each participant will be followed for 2 years after the implantations. All side effects related to the spine will be documented throughout the study.
Who can participate
Age range
22 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or Female between 22 and 85 years of age
* One (single) vertebral fracture which meets all the following criteria:
* Type A fractures as defined by the AO spine classification (compression injuries)1
* Vertebral fracture located in the thoracic and lumbar regions of the spine
* Fracture age \<6 weeks or fractures with anatomic signs of reducibility (based on radiographic evidence as well as patient history)
* Vertebral fracture shows an estimated height loss in the anterior or mid third of the vertebral body (VB) of at least 10% but not more than 70% based on radiographic evidence
* Target VB has appropriate anatomy, i.e., suitable pedicle diameter, pedicle length and chord length that would allow for selection of correct implant size, as described in the IFU and based on axial MRI/CT scan before surgery Patient has a Numerical Pain Rating Scale (NPRS) back pain score of ≥5
* Patient has an Oswestry Disability Index (ODI) score of ≥30/100
* Patient has a BMI \<35
* Patient is mentally capable of complying with trial protocol requirements for the duration of the study
* Patient can understand the risks and benefits of participating in the study and can provide written informed consent
* Patient is available for all study visits
Exclusion Criteria:
* Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
* Non-mobile fractures (i.e., fracture is not recent (\>6 weeks), bone marrow oedema or fluid or empty …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.