A Prospective, Multicenter, Open-Label, Post-Market Study to Evaluate The Effectiveness and Safety of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Wiltrom Co., Ltd.
- Enrollment
- 53
- Locations
- 8
- Primary Endpoint
- Proportion of participants with study success
Study Overview
Brief Summary
The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.
Detailed Description
This study is a prospective, multicenter, open-label, single-arm, PMCF study. The sample size for this study will be 50 patients. Eligible patients will be treated with Tripod-Fix on Day 0 and will be followed for a total of 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of signed and dated informed consent form prior to any study procedures
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Skeletally mature males and females
- •1 painful VCF which meets all of the following criteria:
- •Fracture due to diagnosed or presumed underlying osteoporosis (T-score < -2.5 points)
- •VCF between T6 and L5
- •VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline.
- •The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).
- •Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.
Exclusion Criteria
- •Tripod-Fix is not indicated for any other application other than that for which it is designed. contraindications for Tripod-Fix include, but are not limited to: .
- •Patient presenting a loss of vertebral height >50% compared to estimated pre-fracture height
- •Sclerotic fracture
- •Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
- •Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
- •Active infection (systemic or in the target vertebra)
- •Patient suffering from a severe or uncontrolled systemic disease
- •Patient presenting a pathological fracture with the presence of a mass within the spinal canal
- •Patient presenting neurological damage caused by vertebral fracture
- •Patient pregnant or likely to be so or breastfeeding
- •Patient vertebral anatomy not compatible with the size of the implant or instrumentation
- •Fracture geometry making the insertion of the implant impossible
Outcomes
Primary Outcomes
Proportion of participants with study success
Time Frame: 12 months post-procedure
Study success is defined as follows: 1. The reduction of Visual Analogue Scale (VAS) score \> 20 mm at the 12 month follow up visit compared to baseline as measured by the 100-mm VAS measurement, AND 2. Maintenance or improvement in function at the 12 month follow up visit compared to baseline as measured by the 100-point Oswestry Disability Index (ODI) AND, 3. Absence of device-related serious adverse events.
Secondary Outcomes
No secondary outcomes reported