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Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

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

Record History

  1. Primary completion date: Aug 31, 2028 to Dec 31, 2031
    • Start date: Sep 28, 2022 to Mar 7, 2023
    • Study completion date: Nov 30, 2028 to Apr 30, 2032
    • Site contact updated
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Sep 28, 2022
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT05555459
Lead Sponsor Inion Oy
Conditions
(from sponsor)		 Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture, Calcaneus Fracture, Navicular Fracture, Deformity, Foot, Ankle Fractures +11 more
Related terms Ankle Fractures, Ankylosis, Foot Deformities, Foot Injuries, Fractures, Bone, Hallux Rigidus, Hallux Valgus, Metatarsalgia
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov