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Knee OsteoarthritisNCT05661162

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

A study testing CR 500™ SINGLE-DOSE GEL in people with Knee Osteoarthritis, run by Contrad Swiss SA at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
CR 500™ SINGLE-DOSE GEL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteItaly
Study dates
17 Feb 2021to 18 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

    Castellanza, Varese, 21053

Other trials in Italy

About this study

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

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).

Read the 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.

Being tested
CR 500™ SINGLE-DOSE GEL
Keywords
Knee osteoarthritis;, Hyaluronic acid, Peptides, Synovial fluid, Algofunctional scores, Biochemical markers, Macrophages infiltration
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CR 500™ SINGLE-DOSE GELDevice

    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

Study groups in NCT05661162
Study groupRoleWhat they receive
CR500 single-dose gelOtherInterventional study on CR500 1.5 mL will be topically administered twice a week for four weeks
Receives: Device: CR 500™ SINGLE-DOSE GEL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks

Secondary outcomes (13)

  1. 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

    Measured: 4 weeks

  2. 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

    Measured: 4 weeks

  3. 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

    Measured: 4 weeks

  4. 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

    Measured: 4 weeks

  5. 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.

    Measured: 4 weeks

  6. 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

    Measured: 4 weeks

  7. 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)

    Measured: 4 weeks

  8. 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)

    Measured: 4 weeks

  9. 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)

    Measured: 4 weeks

  10. 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)

    Measured: 4 weeks

  11. 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)

    Measured: 4 weeks

  12. 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)

    Measured: 4 weeks

  13. 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study start17 Feb 2021
  3. Primary completion18 May 2021
  4. Study completion18 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05661162
Sponsor's protocol ID
CTD-SW CR500-KOA 2020
Status last verified
Nov 2022
First submitted
16 Nov 2022
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37573322

Questions about this trial

What is this clinical trial studying?

A study testing CR 500™ SINGLE-DOSE GEL in people with Knee Osteoarthritis, run by Contrad Swiss SA at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OA evaluation, measured by Lequesne Knee Index (LKI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05661162, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

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