ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02480868|
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: ARTEBONE||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Clinical Investigation to Assess Safety and Performance of ARTEBONE as Bone Void Filler in a Single Arthrodesis Procedure of the Ankle (Ankle Joint or Subtalar Joint)|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 14, 2017|
|Actual Study Completion Date :||December 14, 2017|
Bone Void Filler
4,3 g Bone Void Filler
- The incidence of unanticipated serious adverse device effects [ Time Frame: Before or at 12 months ]
- Bone fusion rates [ Time Frame: At 6 months (plus or minus 2 weeks) ]Bone fusion rates assessed by sequential post-operative radiographs and Computer tomography at 6 months (both evaluated by two independent radiologists).
- Bone fusion rates [ Time Frame: At 12 months (plus or minus 2 weeks) ]Bone fusion rates assessed by sequential post-operative radiographs at 12 months (evaluated by two independent radiologists).
- Adverse events [ Time Frame: Within 12 months ]
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-points for returning to work [ Time Frame: Within 12 months ]Secondary performance endpoint
- Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale) [ Time Frame: 6 months (plus or minus 2 weeks) ]Functional performance at 6 months, secondary performance endpoint
- Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale) [ Time Frame: 12 months (plus or minus 2 weeks) ]Functional performance at 12 months, secondary performance endpoint
- Subjective pain evaluation (VAS) for fusion site and at weight bearing [ Time Frame: 12 weeks (plus or minus 1 week) ]Secondary performance endpoint
- Subjective pain evaluation (VAS) for fusion site and at weight bearing [ Time Frame: 6 months (plus or minus 2 weeks) ]Secondary performance endpoint
- Subjective pain evaluation (VAS) for fusion site and at weight bearing [ Time Frame: 12 months (plus or minus 2 weeks) ]Secondary performance endpoint
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480868
|Central Hospital of Central Finland|
|Jyväskylä, Finland, 40620|
|South Karelia Central Hospital|
|Lappeenranta, Finland, 53101|
|Oulu University Hospital|
|Oulu, Finland, 90220|
|Helsinki University Central Hospital Peijas|
|Vantaa, Finland, 00029|
|Autonomous Public Clinical Hospital No. 1 of Pomeranian Medical University in Szczecin named after professor Tadeusz Sokołowski|
|Szczecin, Poland, 71252|
|Principal Investigator:||Juhana Leppilahti, Professor||Oulu University Hospital|