Hallux Valgus Clinical Trial
Official title:
The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle
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.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | November 30, 2028 |
Est. primary completion date | August 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Read the patient information bulletin on the study and signed the patient consent form 2. Adult patient (over 18-year-old) 3. 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, according to a statement of the investigator surgeon 4. Ability to fill in questionnaires. 5. Willingness to comply with rehabilitation instructions. 6. Availability for follow-up visits. Exclusion Criteria: 1. Active infection 2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb 3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder) 4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.) 5. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation 6. Patients with significant neuropathy 7. Pregnancy 8. Patients who refuse to participate 9. Lower limb tumor or metastasis 10. Complex Regional Pain Syndrome (CRPS) in operated foot |
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Inion Oy |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines | X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines | Change from operation to 4 years | |
Primary | Occurrence of adverse events (AEs) | Assessment of occurrence of adverse events (AE), such as non-union of bone, fixation failure, mechanical irritation and tissue reactions related to implant bioabsorption | During 4-year follow-up | |
Primary | Occurrence of revision surgeries | Assessment of occurrence of revision surgeries related to study device | During 4-year follow-up | |
Secondary | Subjective functionality of the operated foot or ankle (VAS foot and ankle) | Evaluation of subjective pain of the operated foot or ankle during follow-up | Change from baseline to 4 years | |
Secondary | Subjective functionality of the operated foot or ankle (EFAS) | Evaluation of subjective functionality of the operated foot or ankle during follow-up | Change from baseline to 4 years | |
Secondary | Wound and soft tissue healing | Assessment of post-operative complications (wound and soft tissue healing based on inspection and palpation) | Change from operation to 3 months | |
Secondary | Fixation strength | X-ray evaluation of the maintaining of fixation position | Change from operation to 4 years | |
Secondary | Bone formation in screw tunnel | X-ray evaluation of the level of bone formation in screw tunnel | Change from operation to 4 years |
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