Prospective Observational Study of Pain Evolution in Patients With Primary Knee Osteoarthritis Treated With Pronolis® HD

Completed

• Conditions: Osteo Arthritis Knee

• Registration Number: NCT04196764
• Lead Sponsor: Procare Health Iberia S.L.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-28
• Primary Completion: 2019-02-21
• Study Completion: 2019-10-21
• Status Verified: 2019-12
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

1. Patients of both sexes and over 18 years.
2. Patients with a previous diagnosis of primary knee osteoarthritis according to ACR criteria and who have a knee x-ray performed during the previous 18 months.
3. Patients who attend a control clinic for primary osteoarthritis of symptomatic knee.
4. Patients with pain equal to or greater than 4 on the VAS scale.
5. Patients who have been prescribed an injection of Pronolis® HD as part of the usual clinical practice.
6. Patients who have given their written informed consent to participate in the clinical investigation.
7. Patients for whom there is a reasonable expectation of follow-up during the development of clinical research.
8. Patients who understand and can complete the questionnaires and do not have cognitive impairment that prevents it.

Exclusion Criteria

1. Patients with known intolerance to hyaluronic acid.
2. Patients with hypersensitivity to intraarticular injections.
3. Patients who present with infection in the knee joint.
4. Patients presenting with a skin disorder or infection in the area of injection or systemic.
5. Coagulation disorders that contraindicate puncture.
6. Patients who have been prescribed intra-articular injection in both knees.
7. Patients diagnosed with autoimmune rheumatologic diseases or connective diseases.
8. Patients diagnosed with microcrystalline diseases.
9. Patients with traumatic history in the study joint.
10. Patients with a surgical history in the study joint.
11. Pregnant or breastfeeding women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evolution of pain in patients diagnosed with primary knee osteoarthritis 3 months after being treated with hyaluronic acid	3 months	3-month baseline change in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution.

Secondary Outcome Measures

Name	Time	Method
tolerability of treatment with Pronolis® HD	15 days, 1, 3 and 6 months	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
satisfaction degree with Pronolis® HD	15 days, 1, 3 and 6 months	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
Pain evolution in motion	15 days, 1, 3 and 6 months	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.
evolution of pain in patients diagnosed with primary knee osteoarthritis during the study	15 days, 1 and 6 months	Changes in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution.
evolution of the patient's functional capacity	15 days, 1, 3 and 6 months	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.
evolution of the patient's quality of life	3 months	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.
stiffness evolution	15 days, 1, 3 and 6 months	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.
overall clinical impression	15 days, 1, 3 and 6 months	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.

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain