Clinical trial NCT06270173: Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoporotic Vertebral Compression Fractures
Lead sponsor: Wiltrom Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2024-02-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form prior to any study procedures
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Skeletally mature males and females
4. 1 painful VCF which meets all of the following criteria:

   1. Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points)
   2. VCF between T6 and L5
   3. 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.
   4. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).
5. 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: .

1. Patient presenting a loss of vertebral height \>50% compared to estimated pre-fracture height
2. Sclerotic fracture
3. Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
4. Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
5. Active infection (systemic or in the target vertebra)
6. Patient suffering from a severe or uncontrolled systemic disease
7. Patient presenting a pathological fracture with the presence of a mass within the spinal canal
8. Patient presenting neurological damage caused by vertebral fracture
9. Patient pregnant or likely to be so or breastfeeding
10. Patient vertebral anatomy not compatible with the size of the implant or instrumentation
11. Fracture geometry making the insertion of the implant impossible

Primary outcomes:
measure: Proportion of participants with study success
timeFrame: 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: University Hospital Mannheim
state: Baden-Württemberg
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe University Frankfurt/Main
state: Hesse
city: Mechernich
country: Germany
facility: Krankenaus Mechernich
state: North-Rhine-Westphalia
Study officials:
affiliation: Wiltrom Co., Ltd.
name: Te-Yang Tsai
role: STUDY_DIRECTOR
References: