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

NCT05661162 | Completed DMC

• 1 other identifier: CTD-SW CR500-KOA 2020
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis;; Hyaluronic acid; Peptides; Synovial fluid; Algofunctional scores; Biochemical markers; Macrophages infiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Lequesne Knee Index (LKI) Score

  4 weeks

• Lequesne Knee Index (LKI) Subscore

  4 weeks

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

  4 weeks

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

  4 weeks

• Number of participants with treatment-related adverse event as assessed by a questionnaire.

  4 weeks

Study Arms (1)

CR500 single-dose gel

OTHER

Interventional study on CR500 1.5 mL will be topically administered twice a week for four weeks

Device: CR 500™ SINGLE-DOSE GEL

Interventions

CR 500™ SINGLE-DOSE GEL DEVICE

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

CR500 single-dose gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Contrad Swiss SA: lead

Study Sites (1)

Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

Castellanza, Varese, 21053, Italy

Location

Related Publications (1)

• Colombini A, Doro G, Ragni E, Forte L, de Girolamo L, Zerbinati F. Treatment with CR500(R) improves algofunctional scores in patients with knee osteoarthritis: a post-market confirmatory interventional, single arm clinical investigation. BMC Musculoskelet Disord. 2023 Aug 12;24(1):647. doi: 10.1186/s12891-023-06754-7.

  PMID: 37573322 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 22, 2022
• Study Start: February 17, 2021
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-11

Locations

IT (1)