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NCT05555459
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
NA trial testing Operation in Medial Malleolus Fracture in 125 participants. Currently enrolling.
31 December 2031
Quick facts
| Lead sponsor | Inion Oy |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 7 March 2023 |
| Primary completion | 31 December 2031 |
| Estimated completion | 30 April 2032 |
| Sites | 1 location across Finland |
Drugs / interventions tested
- Operation
Conditions studied
- Medial Malleolus Fracture — all drugs for Medial Malleolus Fracture →
- Lisfranc Injury — all drugs for Lisfranc Injury →
- Lisfranc Fracture — all drugs for Lisfranc Fracture →
- Talus Fracture — all drugs for Talus Fracture →
Sponsor
Inion Oy — full company profile →
Who can join
18 and older, any sex, with Medial Malleolus Fracture or Lisfranc Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05555459
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05555459 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Inion Oy
- Last refreshed: 13 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05555459.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing