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

NCT05555459 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Medial Malleolus Fracture
  • Lisfranc Injury
  • Lisfranc Fracture
  • Talus Fracture
  • Calcaneus Fracture
  • Navicular Fracture
  • Deformity, Foot
  • Ankle Fractures
  • Foot Fracture
  • Fractures, Bone
  • Fracture of Foot
  • Foot Deformities
  • Foot Injury
  • Feet Deformity Tarsus
  • Metatarsalgia
  • Hallux Rigidus
  • Hallux Valgus
  • Deformity of Toe
  • Deformity of Foot

Interventions

PROCEDURE

Operation

Bone fixation operation in foot or ankle area using bioabsorbable headless screw/s

Sponsors & Collaborators

  • Inion Oy

    lead INDUSTRY

Principal Investigators

  • Mäenpää · Tampere University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2031-12-31
Completion
2032-04-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555459 on ClinicalTrials.gov