Knee OsteoarthritisNCT07322770
Retrospective Evaluation of the Long-term Effectiveness of the CR500™ SINGLE-DOSE GEL Medical Device in Patients With Knee Osteoarthritis (KOA)
An observational study of Knee Osteoarthritis, run by Contrad Swiss SA at 1 site in Italy.
Trial summary
Evaluate the long-term efficacy of the CR500™ therapy in patients with knee OA. 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
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2025to 13 Aug 2025
- Phase
- Observational
- 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
Study population: Participants in the CTD-SW CR500™-KOA 2020 clinical study
Who may be able to join
- Oral informed consent from the patient.
- Participation in the CTD-SW CR500™-KOA 2020 clinical study.
- Willingness to participate in the survey.
Who cannot join
- Patients who were excluded following major protocol violations during the CTD-SW CR500™-KOA 2020 clinical study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas
Castellanza, VARESE, 21053
About this study
Official 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
Evaluate the long-term efficacy of the CR500™ therapy in patients with knee OA.
Read the detailed description
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
- Conditions
- Knee Osteoarthritis
- Being tested
- CR 500™ SINGLE-DOSE GEL
- Keywords
- Hyaluronic Acid, Algofunctional Scores, Peptides, Knee Osteoarthritis, Topical Treatment, Patient Satisfaction
- Medical subject headings
- Osteoarthritis, Knee, Patient Satisfaction
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 group | Role | What they receive |
|---|---|---|
| CR500 single-dose gel | This retrospective phone follow-up involves the 35 patients who completed the CTD-SW CR500™-KOA 2020 study. After obtaining consent, patients will be asked whether and when they required further therapeutic interventions for KOA after the trial. This information will describe the long-term course of each arm by identifying subsequent treatments needed beyond the interventions originally administered during the study. Receives: Device: CR 500™ SINGLE-DOSE GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lequesne Knee Index (LKI) Score
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
Measured: At least after 24 Months from the end of NCT05661162 study visit
Secondary outcomes (4)
Need for additional therapies before and after CR500™.
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
Measured: At least after 24 Months from the end of NCT05661162 study visit.
Timing and type of other interventions performed on the same knee with KOA treated with CR500™ in the NCT05661162 study.
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)?
Measured: At least after 24 Months from the end of NCT05661162 study visit
Long-term satisfaction with the CR500™ treatment.
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
Measured: At least after 24 Months from the end of NCT05661162 study visit
Recurrence of pain in the CR500™-treated knee and prosthesis status.
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?
Measured: At least after 24 Months from the end of NCT05661162 study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start17 Feb 2025
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contrad Swiss SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322770
- Sponsor's protocol ID
- CTD-SW CR500™-KOA 2020 - FU 25
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 7 Jan 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07322770
- Acronym / sponsor ID
- CTD-SW CR500™-KOA 2020 - FU 25
- Conditions
- Knee Osteoarthritis
- Keywords
- Hyaluronic Acid, Algofunctional Scores, Peptides, Knee Osteoarthritis, Topical Treatment, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Contrad Swiss SAIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the long-term efficacy of the CR500™ therapy in patients with knee OA.
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CR500 single-dose gel | – | Device: CR 500™ SINGLE-DOSE GELThis retrospective phone follow-up involves the 35 patients who completed the CTD-SW CR500™-KOA 2020 study. After obtaining consent, patients will be asked whether and when they required further therapeutic interventions for KOA after the trial. This information will describe the long-term course of each arm by identifying subsequent treatments needed beyond the interventions originally administered during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the CTD-SW CR500™-KOA 2020 clinical study
Key inclusion criteria (3 listed)
- Oral informed consent from the patient.
- Participation in the CTD-SW CR500™-KOA 2020 clinical study.
- Willingness to participate in the survey.
Key exclusion criteria (1 listed)
- Patients who were excluded following major protocol violations during the CTD-SW CR500™-KOA 2020 clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CR 500™ SINGLE-DOSE GELCR 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 | Device | CR500 single-dose gel |
Primary outcome
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
4 secondary outcomes
Need for additional therapies before and after CR500™.
Time frame: At least after 24 Months from the end of NCT05661162 study visit.
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
Long-term satisfaction with the CR500™ treatment.
Time frame: At least after 24 Months from the end of NCT05661162 study visit
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Results publication: PubMed 37573322Colombini 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 1 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 7 Jan 2026. 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?
Lequesne Knee Index (LKI) Score (time frame: At least after 24 Months from the end of NCT05661162 study visit). 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 NCT07322770, 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 7 Jan 2026.