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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661162
• Other study ID #: CTD-SW CR500-KOA 2020
• Status: Completed
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: May 18, 2021

Study information

• Verified date: November 2022
• Source: Contrad Swiss SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• CR 500™ SINGLE-DOSE GEL
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

Locations

Country	Name	City	State
Italy	Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas	Castellanza	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Contrad Swiss SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	Number of participants with treatment-related adverse event as assessed by a questionnaire.	To evaluate the side effects of the product CR 500™ through a the completion of a specific questionnaire by the patient.	4 weeks
Secondary	Product tolerability and patient satisfaction as assessed by a questionnaire using a five-points Likert scale	To evaluate the tolerability and patient satisfaction of the CR 500™ 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	4 weeks
Secondary	Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen (C2C)	Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen in synovial fluid by ELISA (ng/mL)	4 weeks
Secondary	Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen (CTX-II)	Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen quantification (CTX-II) in synovial fluid by ELISA (pg/mL)	4 weeks
Secondary	Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) quantification	Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) in synovial fluid by ELISA (ng/mL)	4 weeks
Secondary	Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) quantification	Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) in synovial fluid by ELISA (mg/mL)	4 weeks
Secondary	Evaluation of the inflammatory status of the knee joint by quantification of tumour necrosis factor (TNF) quantification	Evaluation of the status of the cartilage by quantification of tumour necrosis factor (TNF) in synovial fluid by ELISA (pg/mL)	4 weeks
Secondary	Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206)	Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206) by Real Time Polymerase Chain Reaction (PCR)	4 weeks
Secondary	Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c)	Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c) by Real Time PCR	4 weeks