Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)

Contrad Swiss SA38 enrolled

Overview

Single arm clinical investigation, post-market confirmatory interventional to assess performance, safety and tolerability of "CR500 SINGLE-DOSE GEL" medical device in patients with knee osteoarthritis (KOA).

Subjects 26-83 years old will receive CR500 SINGLE-DOSE GEL given for the treatment of osteoarthritis of the knee over a 4-week time period. The primary objective of the study is to evaluate the effect of CR500 SINGLE-DOSE GEL in the treatment of KOA.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

CR 500™ SINGLE-DOSE GELDEVICE

CR 500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, useful to attenuate the physiological degeneration of cartilage typical of osteoarthritic processes. The presence of sodium hyaluronate facilitates the movement of joints and tendons for greater mobility and flexibility

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Male or Female, aged ≥18 years at the time of the signature of ICF (Informed Consent Form). 2. Patients with a diagnosis of primary or secondary KOA affecting only one knee (monolateral KOA) of "mild" (score 1 - 4) or "moderate" (score 5 - 7) severity according to the LKI score. 3. Willing to follow all study procedures, including attending all site visits, tests and examinations. 4. Willing to participate in the study and sign the ICF. Exclusion criteria 1. Osteoarthritis (OA) in both knees (bilateral KOA). 2. Other - different - clinical conditions of the knee. 3. Infective or inflammatory processes near the area of treatment. 4. Damaged skin in the area of treatment. 5. Ongoing cutaneous allergies. 6. Serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy. 7. Allergy to device components (Sodium hyaluronate; Synthetic Human (SH)-Polypeptide-85; SH-Polypeptide-93; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; Polyethylene Glycol (PEG)-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA). 8. Any other systemic or local therapy for the treatment of KOA. 9. Any other systemic or local therapy (e.g. NSAIDs, corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of KOA under treatment with the medical device CR500. 10. Immune system illnesses. 11. Uncontrolled systemic diseases. 12. Known drug and/or alcohol abuse. 13. Mental incapacity that precludes adequate understanding or cooperation. 14. Participation in another investigational study. 15. Pregnancy\* or breastfeeding.

Locations (1)

Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

Castellanza, Varese, Italy

Outcomes

Primary Outcomes

OA evaluation, measured by Lequesne Knee Index (LKI)

The primary efficacy endpoint of the study will be the evaluation of the clinical performance of the CR 500™, used as intended in patients affected by KOA, in variation of symptoms related to the physiological degeneration of cartilage typical of osteoarthritic processes, in terms of difference in LKI score between the end study visit and baseline visit. Lequesne Knee Index Score: minimum index score: 0 maximum index score: 24 0 means none OA \>= means extremely severe OA

Time frame: 4 weeks

Secondary Outcomes

Lequesne Knee Index (LKI) Score

To evaluate the clinical performance of the CR 500™ across the study by Lequesne Knee Index (LKI) score. Lequesne Knee Index Score: minimum index score: 0 maximum index score: 24 0 means none OA \>= means extremely severe OA

Time frame: 4 weeks

Lequesne Knee Index (LKI) Subscore

To evaluate the clinical performance of the CR 500™ by each Lequesne Knee Index (LKI) subscore Lequesne Knee Index Score: minimum index score: 0 maximum index score: 24 0 means none OA \>= means extremely severe OA

Time frame: 4 weeks

Symptoms Variation in terms of Lequesne Knee Index (LKI) score

To evaluate the clinical performance of the CR 500™ in the attenuation of symptoms in patients affected by KOA stratified by KOA severity as assessed by Lequesne Knee Index (LKI) score

Time frame: 4 weeks

Cluster of Subjective Symptoms evaluated by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

To evaluate the different dimensions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire Koos converted into a 0-100 Score 0 means worst level of OA 100 means best level of OA Subscores: Pain, Symptoms, Sports, Quality of Life, Activities of Daily Living

Data from ClinicalTrials.gov

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