The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.
This is a multi-centre, prospective clinical investigation in subjects in need of a single arthrodesis procedure of the ankle (ankle joint or subtalar joint) to relieve persistent pain due to primary or secondary osteoarthritis. The objectives of the study are to assess safety and performance of ARTEBONE as Bone Void Filler in the single arthrodesis procedure of the ankle (ankle joint or subtalar joint). The study will be monitored regularly by Clinical Research Associates (CRAs). Monitoring procedures include one or more visits designed to clarify all prerequisites before the study commences. Interim monitoring visits will take place on a regular basis according to a schedule fixed by mutual agreement. During these visits, the CRA will check for completion of the entries on the Case Report Forms (CRFs), their compliance with the Clinical Investigation Plan (CIP), the standard operating procedures (SOP), Good Clinical Practice and International Organization for Standardization 14155 (ISO 14155), and will compare the CRF entries with the source data, as well as update the Investigator´s File (IF). Source data verification will be performed in an unassisted way (direct access to source documents), unless otherwise required by the local ethics committee. The sample size of 30 subjects was considered adequate for the safety and performance evaluation in this indication based on earlier discussions with the authorities. An interim analyses will be performed for 6 months data. There will be descriptive analysis only and comparison to literature. Literature search has been done according to European Union (EU) guidelines.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
4,3 g Bone Void Filler
Central Hospital of Central Finland
Jyväskylä, Finland
South Karelia Central Hospital
Lappeenranta, Finland
Oulu University Hospital
Oulu, Finland
Helsinki University Central Hospital Peijas
Vantaa, Finland
The incidence of unanticipated serious adverse device effects
Time frame: Before or at 12 months
Bone fusion rates
Bone fusion rates assessed by sequential post-operative radiographs and Computer tomography at 6 months (both evaluated by two independent radiologists).
Time frame: At 6 months (plus or minus 2 weeks)
Bone fusion rates
Bone fusion rates assessed by sequential post-operative radiographs at 12 months (evaluated by two independent radiologists).
Time frame: At 12 months (plus or minus 2 weeks)
Adverse events
Adverse events recorded either voluntarily by the subject in response to a non-leading question (i.e. "how have you been feeling?") or following a clinical observation. All adverse events will be assessed by the investigator according to their severity, relationship to the investigational product, action taken, and outcome status as defined in the ISO14155 guideline.
Time frame: Within 12 months
Time-points for returning to work
Secondary performance endpoint
Time frame: Within 12 months
Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale)
Functional performance at 6 months, secondary performance endpoint
Time frame: 6 months (plus or minus 2 weeks)
Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale)
Functional performance at 12 months, secondary performance endpoint
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Autonomous Public Clinical Hospital No. 1 of Pomeranian Medical University in Szczecin named after professor Tadeusz Sokołowski
Szczecin, Poland
Time frame: 12 months (plus or minus 2 weeks)
Subjective pain evaluation (VAS) for fusion site and at weight bearing
Secondary performance endpoint
Time frame: 12 weeks (plus or minus 1 week)
Subjective pain evaluation (VAS) for fusion site and at weight bearing
Secondary performance endpoint
Time frame: 6 months (plus or minus 2 weeks)
Subjective pain evaluation (VAS) for fusion site and at weight bearing
Secondary performance endpoint
Time frame: 12 months (plus or minus 2 weeks)