the Treatment of Knee Osteoarthritis Clinical Trial
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.
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.
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 (i.e. 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 1:1 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. V1(Day 3): safety visit (3 days after V0) - Objective examination, including measurement of vital parameters (weight, diastolic/systolic 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, diastolic/systolic 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, diastolic/systolic 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 formula,AST, 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01697423 -
Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis
|
Phase 2 |