Calypso Knee System Clinical Study, OUS

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03838978
• Other study ID #: CP0002 (formerly CLIN102918)
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Moximed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: June 2025
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Participants age - 25 to 65 years

2. Body Mass Index (BMI) of < 35, Weight < 300 lbs (136 kg)

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Calypso Knee System (Implantable Shock Absorber)
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.

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Poland	SPORTO	Lódz
Poland	Zagiel Med Hospital	Lublin
Poland	Carolina Medical Center	Warszawa
Poland	Mirai Clinic	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Moximed

Countries where clinical trial is conducted

Belgium,  Poland, 

References & Publications (1)

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 Repor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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: 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)	From baseline to 24 months
Secondary	Time to Full Weight Bearing (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.	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.	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.	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.	From baseline to 24 months