Back to resultsEvaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CR 500™ SINGLE-DOSE GEL
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis;, Hyaluronic acid, Peptides, Synovial fluid, Algofunctional scores, Biochemical markers, Macrophages infiltration
Eligibility Criteria
Inclusion criteria Male or Female, aged ≥18 years at the time of the signature of ICF (Informed Consent Form). 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. Willing to follow all study procedures, including attending all site visits, tests and examinations. Willing to participate in the study and sign the ICF. Exclusion criteria Osteoarthritis (OA) in both knees (bilateral KOA). Other - different - clinical conditions of the knee. Infective or inflammatory processes near the area of treatment. Damaged skin in the area of treatment. Ongoing cutaneous allergies. Serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy. 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). Any other systemic or local therapy for the treatment of KOA. 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. Immune system illnesses. Uncontrolled systemic diseases. Known drug and/or alcohol abuse. Mental incapacity that precludes adequate understanding or cooperation. Participation in another investigational study. Pregnancy* or breastfeeding.
Sites / Locations
- Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CR500 single-dose gel
Arm Description
Interventional study on CR500 1.5 mL will be topically administered twice a week for four weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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.
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
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)
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)
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)
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)
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)
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05661162
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contrad Swiss SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis;, Hyaluronic acid, Peptides, Synovial fluid, Algofunctional scores, Biochemical markers, Macrophages infiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CR500 single-dose gel
Arm Type
Other
Arm Description
Interventional study on CR500 1.5 mL will be topically administered twice a week for four weeks
Intervention Type
Device
Intervention Name(s)
CR 500™ SINGLE-DOSE GEL
Intervention Description
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
Primary Outcome Measure Information:
Title
OA evaluation, measured by Lequesne Knee Index (LKI)
Description
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 Outcome Measure Information:
Title
Lequesne Knee Index (LKI) Score
Description
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
Title
Lequesne Knee Index (LKI) Subscore
Description
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
Title
Symptoms Variation in terms of Lequesne Knee Index (LKI) score
Description
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
Title
Cluster of Subjective Symptoms evaluated by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Description
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
Time Frame
4 weeks
Title
Number of participants with treatment-related adverse event as assessed by a questionnaire.
Description
To evaluate the side effects of the product CR 500™ through a the completion of a specific questionnaire by the patient.
Time Frame
4 weeks
Title
Product tolerability and patient satisfaction as assessed by a questionnaire using a five-points Likert scale
Description
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
Time Frame
4 weeks
Title
Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen (C2C)
Description
Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen in synovial fluid by ELISA (ng/mL)
Time Frame
4 weeks
Title
Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen (CTX-II)
Description
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)
Time Frame
4 weeks
Title
Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) quantification
Description
Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) in synovial fluid by ELISA (ng/mL)
Time Frame
4 weeks
Title
Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) quantification
Description
Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) in synovial fluid by ELISA (mg/mL)
Time Frame
4 weeks
Title
Evaluation of the inflammatory status of the knee joint by quantification of tumour necrosis factor (TNF) quantification
Description
Evaluation of the status of the cartilage by quantification of tumour necrosis factor (TNF) in synovial fluid by ELISA (pg/mL)
Time Frame
4 weeks
Title
Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206)
Description
Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206) by Real Time Polymerase Chain Reaction (PCR)
Time Frame
4 weeks
Title
Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c)
Description
Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c) by Real Time PCR
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Male or Female, aged ≥18 years at the time of the signature of ICF (Informed Consent Form).
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.
Willing to follow all study procedures, including attending all site visits, tests and examinations.
Willing to participate in the study and sign the ICF.
Exclusion criteria
Osteoarthritis (OA) in both knees (bilateral KOA).
Other - different - clinical conditions of the knee.
Infective or inflammatory processes near the area of treatment.
Damaged skin in the area of treatment.
Ongoing cutaneous allergies.
Serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy.
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).
Any other systemic or local therapy for the treatment of KOA.
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.
Immune system illnesses.
Uncontrolled systemic diseases.
Known drug and/or alcohol abuse.
Mental incapacity that precludes adequate understanding or cooperation.
Participation in another investigational study.
Pregnancy* or breastfeeding.
Facility Information:
Facility Name
Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas
City
Castellanza
State/Province
Varese
ZIP/Postal Code
21053
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)
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