Osteoarthritis, KneeNCT04548882
Calypso Knee System Clinical Sub-study, OUS Continued Evaluation
A study testing Calypso Knee System in people with Osteoarthritis, Knee, run by Moximed.
Trial summary
Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Calypso Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2020to 12 Oct 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants age - 25 to 65 years
- Body Mass Index (BMI) of < 35, Weight < 300 lbs
- Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment
Who cannot join
- Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
- Knee ligament or meniscal instability
- Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
About this study
Official title: Continued Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System.
Read the detailed description
This sub-study will be a single-arm, prospective, multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Calypso Knee System
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calypso Knee SystemDevice
Also called Calypso System
The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Calypso Knee System | Experimental | Calypso Knee System Receives: Device: Calypso Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met
- Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain
- Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function
- Freedom from applicable device-related SAEs requiring surgical intervention
- Maintenance of Implant Integrity by Radiographic Review
Measured: Change at 24 months relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start11 Sep 2020
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Why it stopped: Study closed based on continued restrictions around COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moximed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandra Kraenzlin, Study director, Moximed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548882
- Sponsor's protocol ID
- CP0004
- Status last verified
- Nov 2021
- First submitted
- 8 Sep 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
- ClinicalTrials.gov ID
- NCT04548882
- Acronym / sponsor ID
- CP0004
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed based on continued restrictions around COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MoximedIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 16 Sep 2020 (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.
Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System.
Detailed description
This sub-study will be a single-arm, prospective, multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study design
| Arm | Type | Receives |
|---|---|---|
| Calypso Knee System | Experimental | Device: Calypso Knee SystemCalypso Knee System |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants age - 25 to 65 years
- Body Mass Index (BMI) of < 35, Weight < 300 lbs
- Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment
Key exclusion criteria (3 listed)
- Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
- Knee ligament or meniscal instability
- Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
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 |
|---|---|---|
| Calypso Knee SystemAlso: Calypso SystemThe Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis. | Device | Calypso Knee System |
Primary outcome
The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met
Time frame: Change at 24 months relative to baseline
1. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain 2. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function 3. Freedom from applicable device-related SAEs requiring surgical intervention 4. Maintenance of Implant Integrity by Radiographic Review
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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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.
Alexandra Kraenzlin study director
Moximed
Questions about this trial
What is this clinical trial studying?
A study testing Calypso Knee System in people with Osteoarthritis, Knee, run by Moximed.
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 3 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: withdrawn, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met (time frame: Change at 24 months relative to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2021.