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| Name | Class |
|---|---|
| Osteoarthritis Foundation International (OAFI) | UNKNOWN |
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Clinical trial with medical device, multicenter, single-blind (blind third party evaluation), randomized, comparative and in two paralell groups, to demonstrate the treatment according to usual clinical practice, of the combination of 50 mg Sodium Hyaluronate and 50 mg Chondroitin Sulfate (ENKO 1) in a single administration, has non-inferiority efficacy vs the comparator (Durolane; 60 mg HA crosslinked) in patients with symptomatic knee osteoarthritis after three months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENKO 1 | Experimental | ENKO 1 administered by single intra-articular injection. |
|
| Durolane | Active Comparator | Durolane administered by single intra-articular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENKO 1 | Device | 50 mg of HA/ 50 mg of CS in 5 ml |
| |
| Durolane |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | Assessed using VAS (Visual Analogue Scale) Huskisson 0-100mm Pain relief scored on a scale of 0 to 10. 0 means No pain and 10 means worst possible pain. | Change from baseline pain relief at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | Assessed using VAS (Visual Analogue Scale) Huskisson 0-100mm Pain relief scored on a scale of 0 to 10. 0 means No pain and 10 means Worst possible pain. | 0, 1, 6 and 12 weeks. |
| Evaluation of functional WESTERN ONTARIO AND MCMASTER OSTEOARTHRITIS INDEX (WOMAC) index score (Pain subscale) |
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Inclusion Criteria:
Exclusion Criteria:
Other disease-related criteria:
Previous or concomitant treatment-related criteria:
Criteria related to concomitant medication:
Study product-related criteria:
Other criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luisa Varela, Ph, MSc | OPKO Health, Inc. | Study Chair |
| Jordi Monfort, MD, PhD | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Diagonal | Esplugues de Llobregat | Barceloma | 08950 | Spain | ||
| Consell calatà de l'Esport |
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Single-blinded (blind third party evaluation) The physician performing the infiltration will be different and cannot be related to the investigator evaluating the results.
| Device |
60 mg HA crosslinked in 3 ml |
|
Validated questionnaire for patients with osteoarthritis of the knee. 5 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| -7, 0, 1, 6, 12 and 24 weeks. |
| Evaluation of functional WESTERN ONTARIO AND MCMASTER OSTEOARTHRITIS INDEX (WOMAC) index score (Stiffness subscale) | Validated questionnaire for patients with osteoarthritis of the knee. 2 items: after first waking and later in the day. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | -7, 0, 1, 6, 12 and 24 weeks. |
| Evaluation of functional WESTERN ONTARIO AND MCMASTER OSTEOARTHRITIS INDEX (WOMAC) index score (Functional capacity subscale) | Validated questionnaire for patients with osteoarthritis of the knee. 17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | -7, 0, 1, 6, 12 and 24 weeks. |
| Evaluation of percentage of patients who respond to treatment | Evaluation of percentage of patients who respond to treatment according to the OMERACT-OARSI criteria. | 0, 1, 6, 12 and 24 weeks. |
| Global evaluation of the activity of the disease and of the respond to treatment by patient. | Global evaluation of the activity of disease by the patient (VAS (Visual Analogue Scale) from 0-100mm). Scale from 0 to 10, which correspond to: Mild (0-2), Moderate (3-7) and Intense (8-10). where 0 is better outcome and 10 is the worst outcome. | 0, 1, 6, 12 and 24 weeks. |
| Evaluation of Health status of patients | Evaluation of Health status by quality of life questionnaire 12-Item Short Form Survey (SF-12). It consists of 12 items from the 8 dimensions of the SF-36 Physical Function, Social Function, Physical Role, Emotional Role, Mental Health, Vitality, Body Pain, General Health and evaluate intensity and frequency of each item. Scale ranges: Minimum 12 and maximum 60 scores. When 12 means better and 60 is the worse outcome. | 0, 1, 6, 12 and 24 weeks. |
| Evaluation of concomitant medication intake | Daily intake of Paracetamol (maximum 3g/day) | -7, 0, 1, 6, 12 and 24 weeks. |
| Evaluation of synovitis | Clinical valoration of synovial joint swelling. | -7, 0, 1, 6, 12 and 24 weeks. |
| Biomarkers | Blood sample analysis of serum soluble biomarkers according to current validation by THE BIOMARKERS CONSORTIUM. Pre-selected biomarkers: Concentration of Serum CTXI, Serum NTXI, Serum-HA, Serum-PIIANP and Serum CTXII. | -7 and 12 weeks |
| Adverse events | Number of Participants with any Adverse event. | 0, 1, 6, 12 and 24 weeks. |
| Esplugues de Llobregat |
| Barcelona |
| 08950 |
| Spain |
| Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| Clínica Novo Sancti Petri | Chiclana de la Frontera | Cádiz | 11139 | Spain |
| Clínica IQTRA | Torrejón de Ardoz | Madrid | 28002 | Spain |
| Hospital de Torrelodones | Torrelodones | Madrid | 28250 | Spain |
| Clínica Dr. Casermeiro | Mijas Costa | Málaga | 29651 | Spain |
| Instituto Médico Arriaza | A Coruña | 15009 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Instituto POAL del Reumatología | Barcelona | 08022 | Spain |
| Hospital Sant Rafael | Barcelona | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| BiClinic | Madrid | 28027 | Spain |
| AMS Centro Médico del Ejercicio | Málaga | 29004 | Spain |
| Clínica ISMEC | Seville | 41001 | Spain |
| Clínica Gastaldi | Valencia | 46015 | Spain |
| Clínica Traumatológica Dr. Baró | Valladolid | 47004 | Spain |
| Hospital Vithas San José | Vitoria-Gasteiz | 01008 | Spain |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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