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Tests treatment safety and results for Medial Malleolus Fracture
Official title Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
ClinicalTrials.gov ID: NCT05555459
What this study is testing
- What it's testing
- The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult 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 18 and older
You may be able to join if
- Read the patient information bulletin on the study and signed the patient consent form
- Adult patient (over 18-year-old)
- Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws...
- Ability to fill in questionnaires.
- Willingness to comply with rehabilitation instructions.
You likely can't join if
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower 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.)
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
- Patients with significant neuropathy
See the full eligibility criteria
- Read the patient information bulletin on the study and signed the patient consent form
- Adult patient (over 18-year-old)
- Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area...
- Ability to fill in questionnaires.
- Willingness to comply with rehabilitation instructions.
- Availability for follow-up visits.
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower 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.)
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
- Patients with significant neuropathy
- Pregnancy
- Patients who refuse to participate
- Lower limb tumor or metastasis
- Complex Regional Pain Syndrome (CRPS) in operated foot
The study team makes the final eligibility decision.
Where it's taking place
- Tampere, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampere, 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.