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| Name | Class |
|---|---|
| Adknoma Health Research | INDUSTRY |
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Prospective observational study of 6 months of follow-up, of national and multicenter scope with medical device with CE marking and according to the usual clinical practice.
In addition, due to the observational design of the clinical investigation, no assignment of the patients will be made to any specific study group, but will be carried out in accordance with the usual clinical practice, not applying any intervention other than the usual one in this type of care practice and always in accordance with current clinical guidelines and recommendations and with the indications authorized in Spain.
Patients will be recruited by specialists and will be followed for 6 months under the conditions of usual clinical practice.
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| Measure | Description | Time Frame |
|---|---|---|
| evolution of pain in patients diagnosed with primary knee osteoarthritis 3 months after being treated with hyaluronic acid | 3-month baseline change in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| evolution of pain in patients diagnosed with primary knee osteoarthritis during the study | Changes in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution. | 15 days, 1 and 6 months |
| Pain evolution in motion |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be made up of subjects of legal age diagnosed with primary knee osteoarthritis who have pain equal to or greater than 4 measured by VAS.
All patients included in this clinical investigation must have been duly informed by the investigator about the investigation procedure and its objectives.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35546401 | Derived | Calvet J, Khorsandi D, Tio L, Monfort J. Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study. BMC Musculoskelet Disord. 2022 May 11;23(1):442. doi: 10.1186/s12891-022-05383-w. |
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Average score of question A1 of the WOMAC questionnaire will be described at each study visit in order to evaluate pain evolution in motion of the affected joint.
| 15 days, 1, 3 and 6 months |
| stiffness evolution | Average score of domain B of the WOMAC questionnaire will be described at each study visit in order to evaluate the evolution of the stiffness of the affected joint of the patient. In addition, the changes produced between the follow-up visits and the baseline visit will be studied. | 15 days, 1, 3 and 6 months |
| evolution of the patient's functional capacity | Average C domain score of the WOMAC questionnaire will be described at each study visit in orde to assess the evolution of the patient's functional capacity. In addition, the changes produced between the follow-up visits and the baseline visit will be studied. | 15 days, 1, 3 and 6 months |
| evolution of the patient's quality of life | Average score in the 5 dimensions of the Health Questionnaire EQ-5D-5L (mobility, personal care, usual activities, pain / discomfort, anxiety / depression) at the baseline visit and the 3 month visit in order to evaluate the evolution of the patient's quality of life. In addition, the changes produced between the 3-month visit and the baseline visit will be studied. | 3 months |
| satisfaction degree with Pronolis® HD | A likert type scale will be used to assess the patient's satisfaction degree with study treatment in each of the study visits. The evolution of the satisfaction degree (an 5-point Likert Scale) contains 5 items. Higher scores reflected better satisfaction degree | 15 days, 1, 3 and 6 months |
| overall clinical impression | For the evaluation of the overall clinical impression of the change by the patient, the ICG-C score will be described in all follow-up visits. | 15 days, 1, 3 and 6 months |
| tolerability of treatment with Pronolis® HD | percentage of patients who present adverse effects to the treatment during the observation period will be described in order to evaluate the tolerability of hyaluronic acid treatment | 15 days, 1, 3 and 6 months |