Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925595
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-06-22
Brief Title:
Intra-articular Administration of Med Device Made of Biological Vegetal Matrix for the Treatment of Knee Osteoarthritis
Sponsor:
Bios-Therapy Physiological Systems for Health SpA
Organization:
Bios-Therapy Physiological Systems for Health SpA
Study Overview
Official Title:
A Randomized Parallel Group Single Blind Clinical Trial Against Active Comparator to Evaluate the Efficacy and Safety of a Medical Device Made of a Vegetal Biological Matrix for the Treatment of Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pre-market randomized parallel group single-blind clinical study with a Medical Device made of vegetal material to evaluate the efficacy and safety of one knee injection of the investigational device versus active comparator Jonexa The study population will consist of 150 patients diagnosed with primary knee osteoarthrosis At present the study is monocentric competitive
Treatment period for each patient is 6 months
Treatment period for each patient is 6 months
Detailed Description:
150 patients diagnosed with primary knee osteoarthritis will be enrolled by up to 3 centers
The study includes 7 visits at the site center
V-1 eligibility assessment screening visit
Collection of written informed consent
Physical examination including measurement of anthropometric parameters and vital signs height weight diastolic systolic pressure heart rate
Diagnosed with radiologically confirmed primary osteoarthritis of the knee according to American College of Rheumatology criteria ie one or more osteophytes and a measurable joint space on a plain radiograph taken within 3 months prior to screening
Blood tests glycemia creatinine complete blood count with formula ALT AST ALP calcium potassium sodium C reactive protein total bilirubin Urinalysis
Advice on daily diary writing to collect the number of concomitant medication before V0
Recording of adverse events and concomitant therapies in the daily diary
V0 confirmation of possession of selection criteria
Physical examination including measurement of anthropometric parameters and vital signs height weight diastolic systolic pressure heart rate
Randomization 11 to Investigational device or active comparator Jonexa
Intra-articular administration
Observation of the patient for 30 minutes post injection
Compliance with daily diary completion
Administration of questionnaires WOMAC Pain and Function SF-36 and global symptom relief questionnaire CGI- I
Recording of any changes in concomitant therapies and any adverse events
V1Day 3 safety visit 3 days after V0
Objective examination including measurement of vital parameters weight diastolicsystolic blood pressure heart rate
Safety evaluation and AEs recording and Concomitant Therapies
Checking the completion of the daily diary
V2 V2 week 2 2 days follow-up visit
Objective examination including measurement of vital parameters weight diastolicsystolic blood pressure heart rate
Checking the completion of the daily diary
Administration of the global symptom relief questionnaire CGI- I
Administration of the WOMAC Pain questionnaire
Recording of adverse events and concomitant therapies
Instruction to fill in the daily diary via web app smart phone to report the use of all concomitant therapies If patient is not able to use web app a paper copy will be given
V3 V3 week 4 2 days follow-up visit
Objective examination including measurement of vital parameters weight diastolicsystolic blood pressure heart rate
Checking the completion of the daily diary
Administration of the global symptom relief questionnaire CGI- I
Questionnaire administration WOMAC Pain and Function SF-36
Recording of adverse events and concomitant therapies
Instruction to fill in the daily diary via web app smart phone to report the use of all concomitant therapies If patient is not able to use web app a paper copy will be given
V4 V4 week 12 2 days follow-up visit
Physical examination including measurement of anthropometric parameters and vital signs height weight diastolic systolic pressure heart rate
Check of daily diary
Administration of the global symptom relief questionnaire CGI- I
Questionnaire administration WOMAC Pain and Function SF-36
Recording of adverse events and concomitant therapies
Instruction to fill in the daily diary via web app smart phone to report the use of all concomitant therapies If patient is not able to use web app a paper copy will be given
V5 V5 week 24 3 days end-of-study or premature discontinuation visit
Objective examination including measurement of vital parameters
Blood tests blood glucose creatinine blood count with formulaAST ALP calcemia potassium sodium C-reactive protein total bilirubin Urine examination
Check of completion of the daily diary
Administration of the global symptom relief questionnaire CGI- I
Questionnaire administration WOMAC Pain and Function SF-36
Recording of adverse events and concomitant therapies
The study includes 7 visits at the site center
V-1 eligibility assessment screening visit
Collection of written informed consent
Physical examination including measurement of anthropometric parameters and vital signs height weight diastolic systolic pressure heart rate
Diagnosed with radiologically confirmed primary osteoarthritis of the knee according to American College of Rheumatology criteria ie one or more osteophytes and a measurable joint space on a plain radiograph taken within 3 months prior to screening
Blood tests glycemia creatinine complete blood count with formula ALT AST ALP calcium potassium sodium C reactive protein total bilirubin Urinalysis
Advice on daily diary writing to collect the number of concomitant medication before V0
Recording of adverse events and concomitant therapies in the daily diary
V0 confirmation of possession of selection criteria
Physical examination including measurement of anthropometric parameters and vital signs height weight diastolic systolic pressure heart rate
Randomization 11 to Investigational device or active comparator Jonexa
Intra-articular administration
Observation of the patient for 30 minutes post injection
Compliance with daily diary completion
Administration of questionnaires WOMAC Pain and Function SF-36 and global symptom relief questionnaire CGI- I
Recording of any changes in concomitant therapies and any adverse events
V1Day 3 safety visit 3 days after V0
Objective examination including measurement of vital parameters weight diastolicsystolic blood pressure heart rate
Safety evaluation and AEs recording and Concomitant Therapies
Checking the completion of the daily diary
V2 V2 week 2 2 days follow-up visit
Objective examination including measurement of vital parameters weight diastolicsystolic blood pressure heart rate
Checking the completion of the daily diary
Administration of the global symptom relief questionnaire CGI- I
Administration of the WOMAC Pain questionnaire
Recording of adverse events and concomitant therapies
Instruction to fill in the daily diary via web app smart phone to report the use of all concomitant therapies If patient is not able to use web app a paper copy will be given
V3 V3 week 4 2 days follow-up visit
Objective examination including measurement of vital parameters weight diastolicsystolic blood pressure heart rate
Checking the completion of the daily diary
Administration of the global symptom relief questionnaire CGI- I
Questionnaire administration WOMAC Pain and Function SF-36
Recording of adverse events and concomitant therapies
Instruction to fill in the daily diary via web app smart phone to report the use of all concomitant therapies If patient is not able to use web app a paper copy will be given
V4 V4 week 12 2 days follow-up visit
Physical examination including measurement of anthropometric parameters and vital signs height weight diastolic systolic pressure heart rate
Check of daily diary
Administration of the global symptom relief questionnaire CGI- I
Questionnaire administration WOMAC Pain and Function SF-36
Recording of adverse events and concomitant therapies
Instruction to fill in the daily diary via web app smart phone to report the use of all concomitant therapies If patient is not able to use web app a paper copy will be given
V5 V5 week 24 3 days end-of-study or premature discontinuation visit
Objective examination including measurement of vital parameters
Blood tests blood glucose creatinine blood count with formulaAST ALP calcemia potassium sodium C-reactive protein total bilirubin Urine examination
Check of completion of the daily diary
Administration of the global symptom relief questionnaire CGI- I
Questionnaire administration WOMAC Pain and Function SF-36
Recording of adverse events and concomitant therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None