Calypso Knee System Clinical Study

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Calypso Knee System (Implantable Shock Absorber)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Missouri Orthopaedic Institute
Hospital for Special Surgery
Jameson Crane Sports Medicine Institute
Oregon Health and Science University
University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calypso

Arm Description

Calypso Knee System

Outcomes

Primary Outcome Measures

Composite Clinical Success (CCS)

A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following: 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 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 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) Maintenance of implant integrity as evaluated by radiographic assessment Endpoint Subsequent Surgical Intervention (SSI)

Secondary Outcome Measures

Time to Full Weight Bearing (Days)

Any subject that had evaluable data was deemed eligible for effectiveness evaluation and included in the analysis.

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.

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.

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.

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.

Full Information

NCT ID

NCT03671213

First Posted

September 4, 2018

Last Updated

September 6, 2023

Sponsor

Moximed

1. Study Identification

Unique Protocol Identification Number

NCT03671213

Brief Title

Calypso Knee System Clinical Study

Official Title

Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 19, 2018 (Actual)

Primary Completion Date

January 17, 2022 (Actual)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Moximed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Arm Study Design

Masking

None (Open Label)

Allocation

N/A

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Calypso

Arm Type

Experimental

Arm Description

Calypso Knee System

Intervention Type

Device

Intervention Name(s)

Calypso Knee System (Implantable Shock Absorber)

Other Intervention Name(s)

MISHA(TM) Knee System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Composite Clinical Success (CCS)

Description

A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following: 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 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 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) Maintenance of implant integrity as evaluated by radiographic assessment Endpoint Subsequent Surgical Intervention (SSI)

Time Frame

From baseline to 24 months

Secondary Outcome Measure Information:

Title

Time to Full Weight Bearing (Days)

Description

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)

Title

WOMAC Pain Percent Change to Month 3

Description

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

Title

WOMAC Pain Percent Change to Month 24

Description

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

Title

WOMAC Function Percent Change to Month 3

Description

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

Title

WOMAC Function Percent Change to Month 24

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rose Weinstein

Organizational Affiliation

Moximed

Official's Role

Study Director

Facility Information:

Facility Name

Missouri Orthopaedic Institute

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Jameson Crane Sports Medicine Institute

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43202

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Osteoarthritis, Knee

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial