Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function

Knee Osteoarthritis Clinical Trial

Official title:

Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function: a Post-market Confirmatory Interventional, Single Arm Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05886608
• Other study ID #: CTD-SW AI500 2021
• Status: Completed
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: March 16, 2023

Study information

• Verified date: May 2023
• Source: Contrad Swiss SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function

Description:

The aim of this post-market confirmatory interventional clinical investigation is to evaluate the performance and safety of AI500™ SINGLE-DOSE GEL in patients with reduced knee function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed patient informed consent form (ICF).

2. Male or Female aged = 18 years at the time of the signature of ICF.

3. Presenting with reduced knee function caused by osteoarthritis flare-ups, meniscal injuries, ligament injuries, inflammation of soft tissues, assessed as 20-45 rating according to the WOMAC function scale.

4. Willingness to follow all study procedures, including attending all site visits, tests, and examinations.

5. Willingness to follow indications.

Exclusion Criteria:

1. Use of analgesics within the 24 hours prior to V0.

2. Damaged, infected, or ulcerated skin in the area of treatment.

3. Ongoing cutaneous allergies.

4. Serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy.

5. Patients suffering from muscular dystrophy.

6. Patients presenting with bone fractures or severe injuries (including locked knee).

7. Severely disabled arthritic patients using a wheelchair.

8. Allergy to device components (Sodium hyaluronate; SHPolypeptide- 6; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; PEG-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).

9. Immune system illnesses.

10. Uncontrolled systemic diseases.

11. Known drug and/or alcohol abuse.

12. Mental incapacity that precludes adequate understanding or cooperation.

13. Participation in another investigational study.

14. Pregnancy or breastfeeding.

15. Patients with both knees affected/damaged.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Knee Arthritis
• Knee Injuries
• Knee Osteoarthritis
• Knee Pain Swelling
• Osteoarthritis, Knee
• Pain, Acute
• Pain, Chronic

Intervention

Device:
• AI 500™ SINGLE-DOSE GEL
AI500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, intended to provide relief in cases of pain due to tension in muscles and adjacent tissues, to improve movement and function.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Contrad Swiss SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week	To evaluate the clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week of treatment, change from baseline (V0) to week 1 (V3) in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Physical Function score will be evaluated.; 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.	1 Week
Secondary	Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours	To evaluate the clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours of treatment, change from baseline to 48 hours (V2) in WOMAC Physical Function score will be evaluated.; 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.	2 days
Secondary	Clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment.	To evaluate the clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment, change in NRS between V0 and V1, and between V0 and V2 will be analysed.; NRS Score has a range of 0-10 for pain; 0=no pain; 10=max pain.	2 days
Secondary	Safety and Tolerability of AI500™ SINGLE DOSE GEL	To evaluate the safety and tolerability of AI500™ SINGLE DOSE GEL, physical examination and adverse events (AEs), including of the relationship of the AE to the IP (e.g., local allergic reaction), will be assessed through the study.; Safety and tolerability of the AI500™ will be evaluated through a the completion of a specific questionnaire by the patient, the five-points Likert scale in which 1 means Strongly disagree with the assertion and 5 means Strongly agree	1 week