Calypso Knee System Clinical Study



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:25 - 65
Updated:1/27/2019
Start Date:September 19, 2018
End Date:December 2024
Contact:Tessa Yamut
Email:tyamut@moximed.com
Phone:510-887-3389

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

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.

Prospective, multicenter clinical study of the Calypso Knee System. 80 subjects will be
enrolled in this study at up to 10 investigational sites located in the U.S. 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).

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
We found this trial at
4
sites
1100 Virginia Avenue
Columbia, Missouri 65212
Principal Investigator: Seth Sherman, MD
Phone: 573-882-7615
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Columbia, MO
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Dennis Crawford, MD
Phone: 503-418-8673
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Columbus, Ohio 43202
Principal Investigator: David Flanigan, MD
Phone: 614-293-2410
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Columbus, OH
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Andreas Gomoll, MD
Phone: 212-774-2673
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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