Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures

W

Wiltrom Co., Ltd.

Status

Enrolling

Conditions

Osteoporotic Vertebral Compression Fractures

Treatments

Device: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT06270173
TWM-C-2202

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Intervention
Experimental group
Description:
Tripod-Fix will be used to treat osteoporotic vertebral compression fractures.
Treatment:
Device: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)

Trial contacts and locations

4

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Central trial contact

Jill Tseng

Data sourced from clinicaltrials.gov

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