N/A
N=162
Calypso Knee System Clinical Study
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT03671213 ↗Enrolled (actual)
162
Serious AEs
35.2%
Results posted
Jun 2023
Primary outcome: Primary: Composite Clinical Success (CCS) — 83.5; 57.2 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Calypso Knee System (Implantable Shock Absorber) (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Moximed
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Clinical Success (CCS) |
83.5; 57.2 | — |
| SECONDARY Time to Full Weight Bearing (Days) |
13.4; 58 | — |
| SECONDARY WOMAC Pain Percent Change to Month 3 |
-55.5; -33.4 | — |
| SECONDARY WOMAC Pain Percent Change to Month 24 |
-76.0; -64.7 | — |
| SECONDARY WOMAC Function Percent Change to Month 3 |
-52.2; -25.2 | — |
| SECONDARY WOMAC Function Percent Change to Month 24 |
-73.9; -58.8 | — |
Summary
A clinical study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03671213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.