Actively Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Led by Inion Oy · Updated on 2026-03-13
125
Participants Needed
1
Research Sites
477 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.
CONDITIONS
Official Title
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Read the patient information and signed the consent form
- Adult patient (over 18 years old)
- Suitable and need surgical lower limb operation requiring bone fixation with screws in ankle or foot
- Ability to fill in questionnaires
- Willingness to comply with rehabilitation instructions
- Availability for follow-up visits
You will not qualify if you...
- Active infection
- Limited blood supply (severe circulatory disorder of the lower limb)
- Insufficient bone quality or quantity (diagnosed osteoporosis, diabetes, rheumatism, eating disorder)
- Patient cooperation cannot be guaranteed (alcohol use, drug abuse)
- High-load bearing indications unless used with traditional rigid fixation
- Significant neuropathy
- Pregnancy
- Refusal to participate
- Lower limb tumor or metastasis
- Complex Regional Pain Syndrome (CRPS) in operated foot
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tampere University Hospital
Tampere, Finland, 33520
Actively Recruiting
Research Team
M
Marika Manni, MD
CONTACT
K
Kati Marttinen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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