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A 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.
Prospective, multicenter clinical study of the Calypso Knee System. A total of 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calypso Knee System | Experimental | Calypso Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calypso Knee System (Implantable Shock Absorber) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Composite Clinical Success (CCS) | A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following:
| From baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Full Weight Bearing (Days) | Through study completion (number of days to full weight bearing) | |
| WOMAC Pain Percent Change to Month 3 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Flanigan, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Ghent | Belgium | ||||
| SPORTO |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36823955 | Result | Diduch DR, Crawford DC, Ranawat AS, Victor J, Flanigan DC. Implantable Shock Absorber Provides Superior Pain Relief and Functional Improvement Compared With High Tibial Osteotomy in Patients with Mild-to-Moderate Medial Knee Osteoarthritis: A 2-Year Report. Cartilage. 2023 Jun;14(2):152-163. doi: 10.1177/19476035231157335. Epub 2023 Feb 23. |
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The Calypso Clinical Study enrolled 81 subjects in the investigational (Calypso) arm. The historical control arm (HTO) is from a prior Moximed sponsored clinical trial. The results presented include data from the historical control arm for comparison, per the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Calypso Knee System | 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. |
| FG001 | 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). The historical control arm (HTO) is from a prior Moximed sponsored clinical trial. The results presented include data from the historical control arm for comparison, per the protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calypso Knee System | 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. |
| BG001 | High Tibial Osteotomy (HTO) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Composite Clinical Success (CCS) | A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following:
| Posted | Number | percentage of subjects | From baseline to 24 months |
|
Index procedure (enrollment) through 24 months (790 days)
Serious Adverse Events reported as adjudicated as device and/or procedure related by the Clinical Events Committee (CEC).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection: Cellulitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nerve injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Kraenzlin, Director of Clinical Affairs | Moximed, Inc. | +41 44 515 62 06 | akraenzlin@moximed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2022 | May 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Single Arm Study Design
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|
| From baseline to 3 months |
| WOMAC Pain Percent Change to Month 24 | 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. | From baseline to 24 months |
| WOMAC Function Percent Change to Month 3 | 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. | From baseline to 3 months |
| WOMAC Function Percent Change to Month 24 | 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. | From baseline to 24 months |
| Lodz |
| Poland |
| Zagiel Med Hospital | Lublin | Poland |
| Carolina Medical Center | Warsaw | Poland |
| Mirai Clinic | Warsaw | Poland |
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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
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.
| OG001 | 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). |
|
|
|
| Secondary | Time to Full Weight Bearing (Days) | Posted | Mean | Standard Deviation | days | Through study completion (number of days to full weight bearing) |
|
|
|
| Secondary | WOMAC Pain Percent Change to Month 3 | 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. | Posted | Mean | Standard Deviation | percentage of change | From baseline to 3 months |
|
|
|
| Secondary | WOMAC Pain Percent Change to Month 24 | 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. | Posted | Mean | Standard Deviation | percentage of change | From baseline to 24 months |
|
|
|
| Secondary | WOMAC Function Percent Change to Month 3 | 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. | Posted | Mean | Standard Deviation | percentage of change | From baseline to 3 months |
|
|
|
| Secondary | WOMAC Function Percent Change to Month 24 | 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. | Posted | Mean | Standard Deviation | percentage of change | From baseline to 24 months |
|
|
|
| 0 |
| 81 |
| 18 |
| 81 |
| 20 |
| 81 |
| EG001 | 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). | 0 | 81 | 39 | 81 | 14 | 81 |
| Infection: Deep | Infections and infestations | Systematic Assessment |
|
| Infection: Superficial incisional surgical site | Infections and infestations | Systematic Assessment |
|
| Anesthesia Complications: Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Discomfort: Catching or pulling sensations | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Discomfort: Inability to perform certain tasks | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospital readmission: Removal of implant due to dissatisfaction | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nerve injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other: Other, bone consolidation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain: Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Scar formation: Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Scar formation: Periprosthetic adhesions/fibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling: Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Wound: Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Wound: Wound dehiscence (post-explant) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Psychological event: Other | Psychiatric disorders | Systematic Assessment |
|
| Bleeding: Hematoma | Vascular disorders | Systematic Assessment |
|
| Thrombophlebitis: Superficial Thrombophlebitis | Vascular disorders | Systematic Assessment |
|
| Pain: Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Institution agrees study is multi-center study conducted by Sponsor and agrees not to publish until study completion and not before publication of multicenter results in peer-reviewed journal. Thereafter, Institution may publish its site experience. Sponsor reserves exclusive right to publish results and establish authorship based on compliance, contribution and acceptance of responsibilities. If no publication submitted by Sponsor within 12 months of study closure, Institution may publish.
| D012216 |
| Rheumatic Diseases |