Clinical trial NCT03838978: Calypso Knee System Clinical Study, OUS
Official title: Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Moximed
Sponsor class: INDUSTRY
First posted: 2019-02-12
Enrollment: 81
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Arm Study Design
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Composite Clinical Success (CCS)
timeFrame: From baseline to 24 months
Secondary outcomes:
measure: Time to Full Weight Bearing (Days)
timeFrame: Through study completion (number of days to full weight bearing)
measure: WOMAC Pain Percent Change to Month 3
timeFrame: From baseline to 3 months
measure: WOMAC Pain Percent Change to Month 24
timeFrame: From baseline to 24 months
measure: WOMAC Function Percent Change to Month 3
timeFrame: From baseline to 3 months
measure: WOMAC Function Percent Change to Month 24
timeFrame: From baseline to 24 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Lublin
country: Poland
facility: Zagiel Med Hospital
city: Warszawa
country: Poland
facility: Carolina Medical Center
city: Warszawa
country: Poland
facility: Mirai Clinic
city: Łódź
country: Poland
facility: SPORTO
Study officials:
affiliation: Ohio State University
name: David Flanigan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.