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Tests treatment safety and results for Bone Fractures
Official title Study on Safety and Performance of AdvanCore Bone Void Filler
ClinicalTrials.gov ID: NCT06736457
What this study is testing
- What it's testing
- The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult people ≥ 18 years old, male or female.
- people who are eligible for a bone grafting/bone void filler procedure.
- people with bone lesions beyond the limits of the bone's self-healing ability.
- people, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with...
- people with only one fracture susceptible to treatment with an AdvanCore implant.
You likely can't join if
- people with any AdvanCore contraindication for implantation or use.
- people with hypersensitivity to any of the AdvanCore components.
- people with infections or soft/granulation tissue in the area to place bone graft.
- people who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
- Women who are breastfeeding or of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon...
The study team makes the final eligibility decision.
Where it's taking place
- Guimarães, Braga District, Portugal
- Porto, Porto District, Portugal
- Tomar, Santarém District, Portugal
- Lordelo, Vila Real District, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guimarães, Braga District, Portugal; Porto, Porto District, Portugal; Tomar, Santarém District, Portugal; Lordelo, Vila Real District, Portugal. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.