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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: CR 500™ SINGLE-DOSE GEL

• Registration Number: NCT05661162
• Lead Sponsor: Contrad Swiss SA

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.

Study Timeline

• Study Start: 2021-02-17
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Status Verified: 2022-11
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Study First Posted: 2022-12-22
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CR500 single-dose gel	CR 500™ SINGLE-DOSE GEL	Interventional study on CR500 1.5 mL will be topically administered twice a week for four weeks

Primary Outcome Measures

Name	Time	Method
OA evaluation, measured by Lequesne Knee Index (LKI)	4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Symptoms Variation in terms of Lequesne Knee Index (LKI) score	4 weeks	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
Product tolerability and patient satisfaction as assessed by a questionnaire using a five-points Likert scale	4 weeks	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
Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) quantification	4 weeks	Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) in synovial fluid by ELISA (ng/mL)
Lequesne Knee Index (LKI) Score	4 weeks	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
Cluster of Subjective Symptoms evaluated by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire	4 weeks	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
Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen (CTX-II)	4 weeks	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)
Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen (C2C)	4 weeks	Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen in synovial fluid by ELISA (ng/mL)
Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) quantification	4 weeks	Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) in synovial fluid by ELISA (mg/mL)
Number of participants with treatment-related adverse event as assessed by a questionnaire.	4 weeks	To evaluate the side effects of the product CR 500™ through a the completion of a specific questionnaire by the patient.
Lequesne Knee Index (LKI) Subscore	4 weeks	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
Evaluation of the inflammatory status of the knee joint by quantification of tumour necrosis factor (TNF) quantification	4 weeks	Evaluation of the status of the cartilage by quantification of tumour necrosis factor (TNF) in synovial fluid by ELISA (pg/mL)
Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206)	4 weeks	Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206) by Real Time Polymerase Chain Reaction (PCR)
Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c)	4 weeks	Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c) by Real Time PCR

Trial Locations

Locations (1)

Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas; 🇮🇹 Castellanza, Varese, Italy