Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Operation

    Procedure/Surgery

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

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: CompressOn groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines

X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines

Time frame
Change from operation to 4 years
2

Occurrence of adverse events (AEs)

Assessment of occurrence of adverse events (AE), such as non-union of bone, fixation failure, mechanical irritation and tissue reactions related to implant bioabsorption

Time frame
During 4-year follow-up
3

Occurrence of revision surgeries

Assessment of occurrence of revision surgeries related to study device

Time frame
During 4-year follow-up

Secondary outcomes

1

Subjective functionality of the operated foot or ankle (VAS foot and ankle)

Evaluation of subjective pain of the operated foot or ankle during follow-up

Time frame
Change from baseline to 4 years
2

Subjective functionality of the operated foot or ankle (EFAS)

Evaluation of subjective functionality of the operated foot or ankle during follow-up

Time frame
Change from baseline to 4 years
3

Wound and soft tissue healing

Assessment of post-operative complications (wound and soft tissue healing based on inspection and palpation)

Time frame
Change from operation to 3 months
4

Fixation strength

X-ray evaluation of the maintaining of fixation position

Time frame
Change from operation to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inion Oy

Lead sponsor

Source ClinicalTrials.gov
Apply now