Actively Recruiting
Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOn Screws in Pediatric and Adolescent Bone Fracture Fixation of Ankle, Knee, and Elbow
Led by Inion Oy · Updated on 2026-06-03
80
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to follow the safety and performance of the bioabsorbable headless Inion CompressOn Screw used to fix fractures in the ankle, knee, and elbow of children and adolescents. The study focuses on monitoring bone healing and the occurrence of any adverse events or revision surgeries related to the device. It is a post-market clinical follow-up study required to confirm the device's performance compared to a similar approved device, conducted at a single center in Finland. Participants receive surgical fracture fixation using the Inion CompressOn Screw, which is made of degradable polymers that retain strength for about 12 weeks and fully absorb within four years. The study includes 80 pediatric and adolescent patients who meet the criteria. Each patient is followed for four years with six key time points: screening before surgery, operation day, and four post-operative follow-ups at 4-8 weeks, 3 months, 2 years, and 4 years. The last two follow-ups are specifically for study data collection. During the study, participants will undergo assessments to monitor bone healing and ossification at the fracture site, track any device-related adverse events, and note any revision surgeries needed. Questionnaires will assess the function of the operated limb and area over time. The follow-ups beyond standard care provide detailed performance and safety data over four years, ensuring comprehensive monitoring of outcomes related to the implanted device.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by parents or legal guardians and assent from the child if appropriate
- Patient is younger than 18 years
- Has a fracture in need of surgery suitable for the study device
- Able to provide input for patient-reported outcome questionnaires
- Willing and able to follow rehabilitation instructions
- Available for follow-up visits over the study period
You will not qualify if you...
- Active infection
- Conditions causing limited blood supply, such as severe circulatory disorders in limbs
- Insufficient bone quality or quantity, including diagnosed osteoporosis or related conditions
- Inability to cooperate due to factors like alcohol or drug abuse
- Known allergy to the implant materials or their degradation products
- Fractures related to spinal or craniomaxillofacial areas
- High-load bearing fractures unless combined with traditional rigid fixation
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) prior to operation
Duration - Day 0
Participants undergo a surgical fracture fixation procedure using the bioabsorbable Inion CompressOn Screw.
1 operation visit (in-person)
Duration - Up to 3 months after operation
Participants are monitored during the initial healing phase after surgery as part of standard care.
3 visits (at 4-8 weeks, 3 months post-operation)
Duration - Up to 4 years after operation
Participants have scheduled follow-up visits to assess bone healing and safety of the implant beyond standard care.
2 visits (at 2 years and 4 years post-operation)
Trial Site Locations
Total: 1 location
1
Turku University Hospital/Lighthouse hospital
Turku, Finland, 20520
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here