This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h/d).
Signed written informed consent before inclusion in the investigation.
Any gender, any ethnic origin, 19-69 years old inclusive.
Body Mass Index 18.5-40 kg/m2 inclusive.
Full comprehension: ability to comprehend the full nature and purpose of the clinical investigation.
Clinically significant abnormal physical findings which could interfere with the objectives of the investigation
History of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation.
Significant history of diseases that may interfere with the aim of the clinical investigation.
History of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. History of ongoing physical therapy involving the selected knee.
Single group
Knee Heatwraps
DeviceTo treat the painful knee joint in patients with osteoarthritis without acute flares or inflammation. The investigational device will be used in accordance with the Instructions for Use.
Pain intensity
The primary endpoint of this clinical investigation is the change from baseline of pain intensity measured by Visual Analogue Scale (VAS) at Day 4, i.e., after 3 days of treatment. The VAS was chosen for the pain evaluation since it is a simple, quick and easy to use scale, suitable for different populations, such as adults and elderly individuals. Pain intensity will be measured using a 0-100 mm VAS.
Sensorial perceptions evaluation
Results of the sensorial perceptions evaluation collected by a questionnaire. Questionnaire replies will be self-recorded by the patients in their individual diaries.
Pain intensity measured (%)
Percent change and change from baseline of pain intensity measured by VAS. The Visual Analogue Scale was chosen for the pain evaluation since it is a simple, quick and easy to use scale, suitable for different populations, such as adults and elderly individuals.
Functional levels and joint health measured (%)
Percent change and change from baseline in functional levels and joint health measured by Knee Injury and Osteoarthritis Outcome (KOOS) questionnaire at final visit. The questionnaire is an established patient-reported outcome instrument commonly used in clinical research. It is utilized to measure the changes in patient's health status in a standardized way. The questionnaire was chosen since adequate to both older and younger patients, able to combine short and long-term outcomes in a meaningful way and self-administered to patients through a questionnaire. The format is user-friendly and it takes about 10 minutes to fill-in. The standard KOOS questionnaire foresees 5 dimensions: pain, symptoms, activity of daily living, sport and recreation, quality of life. The sport, recreation dimension will not be assessed in this clinical investigation because we expect the enrolment of many elderly patients, for whom this section would not be applicable. The pain is already evaluatedby VAS.
Health status evaluation
Results of the overall health status evaluation performed by the Investigator by the CGI-I scale (Clinical Globally Impression - Improvement). This scale was selected since it is a simple, brief and stand-alone method allowing the clinician to assessing treatment response and overall improvement or worsening of the health conditions in clinical study participants. Sensorial perceptions and subject's satisfaction will be evaluated using questionnaires specifically designed for this purpose for this clinical investigation. CGI-I scale including 7 levels of achieved improvement/worsening (final visit/ETV).
Click on the lead sponsor to view all of their trials.
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead sponsor
Cross Research S.A.
Collaborator
