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NCT Number: NCT07322770

Retrospective Evaluation of the Long-term Effectiveness of the CR500™ SINGLE-DOSE GEL Medical Device in Patients With Knee Osteoarthritis (KOA)

Evaluate the long-term efficacy of the CR500™ therapy in patients with knee OA.

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Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Health Behavior Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Patient Satisfaction Rheumatic Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

Castellanza, VARESE, 21053, Italy

About this study

To assess whether and when the patients enrolled in the CTD-SW CR500™-KOA 2020 clinical study required new orthopaedic treatment for knee osteoarthritis, starting at least 24 months after the conclusion of the clinical study.

Evaluate whether, in the long term, despite the potential bias of other therapies, treatment with CR500 has led to a lasting improvement, especially in comparison with infiltrative treatments based on the literature.

Collect data on patient satisfaction with the therapy received

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Oral informed consent from the patient.
  • Participation in the CTD-SW CR500™-KOA 2020 clinical study.
  • Willingness to participate in the survey.

Exclusion criteria

  • Patients who were excluded following major protocol violations during the CTD-SW CR500™-KOA 2020 clinical study

Treatment and study plan

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

Primary outcomes

  1. Lequesne Knee Index (LKI) Score

    Time frame: At least after 24 Months from the end of NCT05661162 study visit

    The primary efficacy endpoint of the study will be the evaluation of the long-term clinical performance of the CR500™, 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 of NCT05661162 study visit and follow-up visit.

    Lequesne Knee Index Score:

    minimum index score: 0 maximum index score: 24

    0 means none OA

    >= means extremely severe OA

Secondary outcomes

  1. Need for additional therapies before and after CR500™.

    Time frame: At least after 24 Months from the end of NCT05661162 study visit.

    To collect information, via a questionnaire, on the need for joint injections before and after CR500™ therapy.

    Did the patients receive HA infiltration before the therapy with CR500? Yes No

    Had the patients received another treatment for the same pathology after CR500™? Yes No

  2. Timing and type of other interventions performed on the same knee with KOA treated with CR500™ in the NCT05661162 study.

    Time frame: At least after 24 Months from the end of NCT05661162 study visit

    To collect, via a questionnaire, information on the timing and type of other interventions performed on the same KOA-affected knee treated with CR500™ in the NCT05661162 study, as follows:

    After the treatment with CR500 have you undergone any other therapies for the treatment of OA? Yes No

    If yes, which ones? Infiltrative Therapies (HA, PRP, or corticosteroids) Oral anti-inflammatory or pain-relief therapies Topical anti-inflammatory or pain-relief therapies Electromedical therapies Physiotherapy

    Do you roughly remember when (month/year)?

  3. Long-term satisfaction with the CR500™ treatment.

    Time frame: At least after 24 Months from the end of NCT05661162 study visit

    To collect, via a questionnaire, information on long-term patient satisfaction at least 24 months after the last application of CR500™.

    Would you repeat the treatment with CR500™? Yes No Uncertain

  4. Recurrence of pain in the CR500™-treated knee and prosthesis status.

    Time frame: At least after 24 Months from the end of NCT05661162 study visit

    To collect, via a questionnaire, information on the health status of the knee treated with CR500™ (presence of pain after treatment) and on prosthesis status (whether undergone or scheduled).

    After the treatment with CR500, has a similar pain reappeared in the same knee? Yes Yes, but less intense No

    After the treatment with CR500, have you undergone knee replacement surgery? Yes Waiting list No If Yes, when?

Sponsors and collaborators

Lead sponsor

Contrad Swiss SA

Industry

Registry information

Official study title

Retrospective Evaluation of the Long-term Effectiveness of the CR500™ SINGLE-DOSE GEL Medical Device in Patients With Knee Osteoarthritis (KOA) Enrolled in the Clinical Study CTD-SW CR500™-KOA 2020

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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