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Tests treatment safety and results for Ankle Fractures
Official title Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
ClinicalTrials.gov ID: NCT07473947
What this study is testing
- What it's testing
- The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of pediatric and adolescent patients. The study aims to recruit 80 patients who meet the acceptance criteria.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- 1\. Informed consent signed by parents or legal guardians, and assent from the child if of appropriate age and cognitive ability \< 18 years 3...
You likely can't join if
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower or upper limb)
- Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g...
- Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
- Patients with known allergy to the implant constituents or its degradation products.
- Spinal and craniomaxillofacial indications.
See the full eligibility criteria
- 1\. Informed consent signed by parents or legal guardians, and assent from the child if of appropriate age and cognitive ability \< 18 years 3. Suitable and in need for an operation indicated for subject device 4...
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower or upper limb)
- Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
- Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
- Patients with known allergy to the implant constituents or its degradation products.
- Spinal and craniomaxillofacial indications.
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
The study team makes the final eligibility decision.
Where it's taking place
- Turku, Finland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turku, Finland. 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.