Osteoarthritis, Knee
Conditions
Brief 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.
Detailed description
Prospective, multicenter clinical study of the Calypso Knee System. 81 subjects were enrolled in this study. Male or female subjects age 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall WOMAC pain score ≥ 40 (scale 0-100). The Calypso group was investigated under two clinical protocols, CP0001 in the USA, and CP0002 in Europe. Both clinical protocols followed the same supporting protocols and plans, such as radiographic, statistical, Clinical Events Committee (CEC), etc. The results from the combined analysis have been reported in both NCT03671213 (CP0001) and NCT03838978 (CP0002).
Interventions
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.
Sponsors
Moximed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Arm Study Design
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Participants age - 25 to 65 years 2. Body Mass Index (BMI) of \< 35, Weight \< 300 lbs 3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment
Exclusion criteria
1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee 2. Knee ligament or meniscal instability 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Clinical Success (CCS) | From baseline to 24 months | A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following: 1. Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points 2. Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points 3. Freedom from the following device-related serious adverse events: * Deep infection requiring surgical intervention (Both arms) * Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms) * Non-union (HTO only) 4. Maintenance of implant integrity as evaluated by radiographic assessment 5. Endpoint Subsequent Surgical Intervention (SSI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Full Weight Bearing (Days) | Through study completion (Number of days to full weight bearing) | Any subject that had evaluable data was deemed eligible for effectiveness evaluation and included in the analysis. |
| WOMAC Pain Percent Change to Month 3 | From baseline to 3 months | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. |
| WOMAC Pain Percent Change to Month 24 | From baseline to 24 months | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. |
| WOMAC Function Percent Change to Month 3 | From baseline to 3 months | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. |
| WOMAC Function Percent Change to Month 24 | From baseline to 24 months | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Flanigan, MD
Ohio State University
Participant flow
Pre-assignment details
The Calypso Clinical Study enrolled 81 subjects in the investigational (Calypso) arm. This study was compared to a historical control arm (HTO). The results presented include data from the historical control arm.
Participants by arm
| Arm | Count |
|---|---|
| Calypso Knee 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. | 81 |
| High Tibial Osteotomy (HTO) Historical Control: HTO is a surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment OA. All subjects underwent an open wedge osteotomy (OWO). | 81 |
| Total | 162 |
Baseline characteristics
| Characteristic | Calypso Knee System | High Tibial Osteotomy (HTO) | Total |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 7.71 | 52.5 years STANDARD_DEVIATION 7.58 | 51.8 years STANDARD_DEVIATION 7.65 |
| Body Mass Index (BMI) | 28.4 kg/m^2 STANDARD_DEVIATION 3.44 | 29.3 kg/m^2 STANDARD_DEVIATION 4.36 | 28.8 kg/m^2 STANDARD_DEVIATION 3.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 50 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 30 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 80 Participants | 80 Participants | 160 Participants |
| Sex: Female, Male Female | 32 Participants | 28 Participants | 60 Participants |
| Sex: Female, Male Male | 49 Participants | 53 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 81 |
| other Total, other adverse events | 20 / 81 | 14 / 81 |
| serious Total, serious adverse events | 18 / 81 | 39 / 81 |
Outcome results
Primary
Composite Clinical Success (CCS)
A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following: 1. Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points 2. Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points 3. Freedom from the following device-related serious adverse events: * Deep infection requiring surgical intervention (Both arms) * Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms) * Non-union (HTO only) 4. Maintenance of implant integrity as evaluated by radiographic assessment 5. Endpoint Subsequent Surgical Intervention (SSI)
Time frame: From baseline to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Calypso Knee System | Composite Clinical Success (CCS) | 83.5 percentage of subjects |
| High Tibial Osteotomy (HTO) | Composite Clinical Success (CCS) | 57.2 percentage of subjects |
Comparison: For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis
Secondary
Time to Full Weight Bearing (Days)
Any subject that had evaluable data was deemed eligible for effectiveness evaluation and included in the analysis.
Time frame: Through study completion (Number of days to full weight bearing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calypso Knee System | Time to Full Weight Bearing (Days) | 13.4 days | Standard Deviation 10.12 |
| High Tibial Osteotomy (HTO) | Time to Full Weight Bearing (Days) | 58 days | Standard Deviation 39.91 |
Secondary
WOMAC Function Percent Change to Month 24
Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
Time frame: From baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calypso Knee System | WOMAC Function Percent Change to Month 24 | -73.9 percentage of change | Standard Deviation 29.6 |
| High Tibial Osteotomy (HTO) | WOMAC Function Percent Change to Month 24 | -58.8 percentage of change | Standard Deviation 35.8 |
Secondary
WOMAC Function Percent Change to Month 3
Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
Time frame: From baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calypso Knee System | WOMAC Function Percent Change to Month 3 | -52.2 percentage of change | Standard Deviation 32 |
| High Tibial Osteotomy (HTO) | WOMAC Function Percent Change to Month 3 | -25.2 percentage of change | Standard Deviation 37 |
Secondary
WOMAC Pain Percent Change to Month 24
Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
Time frame: From baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calypso Knee System | WOMAC Pain Percent Change to Month 24 | -76.0 percentage of change | Standard Deviation 28.2 |
| High Tibial Osteotomy (HTO) | WOMAC Pain Percent Change to Month 24 | -64.7 percentage of change | Standard Deviation 33 |
Secondary
WOMAC Pain Percent Change to Month 3
Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
Time frame: From baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calypso Knee System | WOMAC Pain Percent Change to Month 3 | -55.5 percentage of change | Standard Deviation 29.3 |
| High Tibial Osteotomy (HTO) | WOMAC Pain Percent Change to Month 3 | -33.4 percentage of change | Standard Deviation 35.8 |