Clinical trial NCT05661162: Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)
Official title: Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA): a Post-market Confirmatory Interventional, Single Arm Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis;
Hyaluronic acid
Peptides
Synovial fluid
Algofunctional scores
Biochemical markers
Macrophages infiltration
Lead sponsor: Contrad Swiss SA
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: OA evaluation, measured by Lequesne Knee Index (LKI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Lequesne Knee Index (LKI) Score
timeFrame: 4 weeks
measure: Lequesne Knee Index (LKI) Subscore
timeFrame: 4 weeks
measure: Symptoms Variation in terms of Lequesne Knee Index (LKI) score
timeFrame: 4 weeks
measure: Cluster of Subjective Symptoms evaluated by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
timeFrame: 4 weeks
measure: Number of participants with treatment-related adverse event as assessed by a questionnaire.
timeFrame: 4 weeks
measure: Product tolerability and patient satisfaction as assessed by a questionnaire using a five-points Likert scale
timeFrame: 4 weeks
measure: Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen (C2C)
timeFrame: 4 weeks
measure: Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen (CTX-II)
timeFrame: 4 weeks
measure: Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) quantification
timeFrame: 4 weeks
measure: Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) quantification
timeFrame: 4 weeks
measure: Evaluation of the inflammatory status of the knee joint by quantification of tumour necrosis factor (TNF) quantification
timeFrame: 4 weeks
measure: Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206)
timeFrame: 4 weeks
measure: Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Castellanza
country: Italy
facility: Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas
state: Varese
Study officials:
References: