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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

StatusRecruiting
PhaseNot applicable
SponsorInion Oy
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Recruitment opened
    • Start date changed from estimate of Apr 2026 to May 29, 2026
    • Site details revised
    v3
  2. Secondary endpoints revised (2)v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Inion Oy
2 trials monitored
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The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of pediatric and adolescent patients. The study aims to recruit 80 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 Lighthouse Hospital at Turku University Hospital (TYKS) in Finland. The main focus of the study in terms of performance is to follow up 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.
Trial Details
NCT Number NCT07473947
Lead Sponsor Inion Oy
Conditions
(from sponsor)		 Ankle Fractures, Knee Fractures, Elbow Fractures
Related terms Ankle Fractures, Elbow Fractures, Knee Fractures
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov