Health Trials

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

ConditionsMedial Malleolus FractureLisfranc InjuryLisfranc FractureTalus FractureCalcaneus FractureNavicular FractureDeformity, FootAnkle FracturesFoot FractureFractures, BoneFracture of FootFoot DeformitiesFoot InjuryFeet Deformity TarsusMetatarsalgiaHallux RigidusHallux ValgusDeformity of ToeDeformity of Foot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInion Oy

About this trial

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.

Eligibility criteria

Qualifiers

Read the patient information bulletin on the study and signed the patient consent form

Adult patient (over 18-year-old)

Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon

Ability to fill in questionnaires.

Disqualifiers

Active infection

Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb

Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)

Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)

Trial design

Treatments tested in this trial

  • Operation

Treatment groups

125 Participants
are divided into 1 treatment group

Sponsors and collaborators

Inion Oy

Lead sponsor

Source ClinicalTrials.gov