Actively Recruiting
Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Foot and Ankle Fracture, Osteotomy, and Arthrodesis Surgeries
Led by Inion Oy · Updated on 2026-03-13
125
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the bioabsorbable headless compression screw called Inion CompressOn in certain foot and ankle surgeries involving fractures, osteotomies, and arthrodeses. This study focuses on adult patients undergoing these operations and aims to assess bone healing and the occurrence of any adverse events or revision surgeries related to the device. The study is conducted as a single-center, single-group investigation at Tampere University Hospital in Finland. The Inion CompressOn screws are made from degradable polymers that maintain their strength for up to 12 weeks after implantation and gradually absorb within two to four years. The devices are used during surgical bone fixation operations for various foot and ankle injuries and deformities, such as medial malleolar fractures, Lisfranc injuries, talus and calcaneal fractures, and several types of arthrodesis and osteotomies. All 125 participants receive surgery using these screws, with follow-up visits planned for up to four years after the operation. Participants will undergo six follow-up visits, starting with a screening visit before surgery, the operation itself, and several post-operative visits at 6 weeks, 3 months, 2 years, and 4 years. The first four visits align with standard care, while the last two are study-specific to gather long-term safety and performance data. Researchers will assess bone healing, adverse events, revision surgeries, wound healing, fixation strength, and patient-reported foot and ankle function over this period.
CONDITIONS
Brief 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...
- Signed the patient information bulletin and consent form
- Adult patient aged 18 years or older
- In need of surgical lower limb operation requiring bone fixation with screws in the ankle or foot
- Able to fill in questionnaires
- Willing to follow rehabilitation instructions
- Available for follow-up visits
You will not qualify if you...
- Active infection
- Severe circulatory disorders or limited blood supply in lower limbs
- Poor bone quality or quantity (e.g., diagnosed osteoporosis, diabetes, rheumatism, eating disorder)
- Conditions that prevent patient cooperation (e.g., alcohol or drug abuse)
- High-load bearing fractures unless combined with traditional fixation
- Significant neuropathy
- Pregnancy
- Refusal to participate
- Lower limb tumor or metastasis
- Complex Regional Pain Syndrome (CRPS) in the operated foot
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 months before operation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo a bone fixation operation in the foot or ankle using bioabsorbable headless screws.
1 visit (in-person)
Duration - Up to 3 months after operation
Participants receive standard post-operative care following the operation.
2 visits (6 weeks and 3 months post-operation, in-person)
Duration - 2 to 4 years after operation
Participants have additional follow-up visits scheduled to monitor bone healing, safety, and functionality of the operated area.
2 visits (2 years and 4 years post-operation, in-person)
Trial Site Locations
Total: 1 location
1
Tampere University Hospital
Tampere, Finland, 33520
Actively Recruiting
Research Team
M
Marika Manni, MD
K
Kati Marttinen
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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