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This study evaluates the efficacy of intra-articular administration of RegenoGel-OSPâ„¢ and RegenoGelâ„¢ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSPâ„¢, RegenoGel or placebo treatment in the first treatment. In the second treatment after interval of three months all the subjects will necessarily receive one of the two active products. The follow-up period will continue for one year after first treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RegenoGel-OSP - RegenoGel-OSP | Experimental | First injection- the patients will receive RegenoGel-OSP; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP also |
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| RegenoGel - RegenoGel | Experimental | First injection- the patients will receive RegenoGel; Second injection (after 3 months interval)- the patients will receive RegenoGel also |
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| Placebo - RegenoGel-OSP | Placebo Comparator | First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP |
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| Placebo - RegenoGel | Placebo Comparator | First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RegenoGel-OSP, RegenoGel | Device | RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy assessment on change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS) | Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here. | Three months |
| Efficacy assessment on change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. | Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (Pain both at rest and during exercise). | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS) | Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel | ||||
| Shaare Zedek |
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| Six months |
| Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score | Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (pain both at rest and during exercise). | Six months |
| Change in the subject´s activity in response to treatments based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score | Change in the subject´s activity in response to treatments based on the entire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. | Three and Six months |
| Change from baseline in quality of life in response to treatments using the SF-12 health survey. | Change from baseline in quality of life in response to treatments using the SF-12 health survey. | Three and Six months |
| Change in Subjective International Knee Documentation Committee score (IKDC). | Change in Subjective International Knee Documentation Committee score (IKDC). | Three and Six months |
| Clinical safety and tolerability assessments which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms. | Clinical safety and tolerability assessments up to 12 months post 1st injection which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms. | Up to 12 months post first injection |
| Jerusalem |
| Israel |
| Meir Medical Center | Kfar Saba | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Assaf Harofe Medical Center | Zrifin | Israel |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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