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Not Applicable
Calypso Knee System for Osteoarthritis
N/A
Waitlist Available
Led By David Flanigan, MD
Research Sponsored by Moximed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants age 25 to 65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 24 months
Awards & highlights
Study Summary
This trial is testing a new knee implant to see if it is safe and effective for people with osteoarthritis.
Who is the study for?
This trial is for people aged 25-65 with persistent knee pain due to osteoarthritis on the inner side, despite non-surgical treatments for at least 6 months. Participants should have a BMI of less than 35 and weigh under 300 lbs. Those with unstable knee ligaments, other joint diseases, metal allergies, infections, certain neurological conditions or taking steroids/chemotherapy are excluded.Check my eligibility
What is being tested?
The Calypso Knee System study tests an implantable shock absorber's safety and effectiveness in individuals with symptomatic osteoarthritis in the medial compartment of their knee.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the implant site, potential allergic reactions to materials used in the device, infection risk post-surgery and possible impact on mobility if complications arise.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Clinical Success (CCS)
Secondary outcome measures
Time to Full Weight Bearing (Days)
WOMAC Function Percent Change to Month 24
WOMAC Function Percent Change to Month 3
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CalypsoExperimental Treatment1 Intervention
Calypso Knee System
Find a Location
Who is running the clinical trial?
MoximedLead Sponsor
6 Previous Clinical Trials
574 Total Patients Enrolled
5 Trials studying Osteoarthritis
251 Patients Enrolled for Osteoarthritis
David Flanigan, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
3 Previous Clinical Trials
210 Total Patients Enrolled
2 Trials studying Osteoarthritis
201 Patients Enrolled for Osteoarthritis
Rose WeinsteinStudy DirectorMoximed
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Osteoarthritis
50 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on steroids or chemotherapy that could affect the study.I have inner knee pain from osteoarthritis despite 6 months of non-surgical treatment.I am between 25 and 65 years old.I have osteoarthritis symptoms in my other knee or in parts of my target knee.I do not have allergies to metals, active infections, or specific neurological conditions.I have a condition like Rheumatoid arthritis, Paget's disease, or Charcot's disease.I am between 25 and 65 years old.Your weight is less than 300 pounds and your body mass index (BMI) is less than 35.My knee is unstable due to a ligament or meniscal issue.
Research Study Groups:
This trial has the following groups:- Group 1: Calypso
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03671213 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which healthcare facilities are managing this experiment within the state?
"The 5 primary clinical trial sites are Oregon Health and Science University in Portland, Hospital for Special Surgery in New york City, and Jameson Crane Sports Medicine Institute in Columbus. Two other locations have been added to the list of qualified test centres."
Answered by AI
What criteria must an individual meet to be eligible for this clinical trial?
"This osteoarthritis trial is recruiting 81 participants aged 25 to 65 years, with a BMI no higher than 35 and body weight not exceeding 300 lbs. Patients must also have experienced inner knee pain persisting over 6 months of non-surgical care."
Answered by AI
Are enrollments for this experiment still being accepted?
"Clinicaltrials.gov has this trial listed as inactive - it was initially posted on September 19th 2018 and last edited on March 2nd 2022. Despite this, 693 other trials are presently seeking participants to join their research teams."
Answered by AI
Does this research protocol require participants to be under 40 years of age?
"The trial guidelines stipulate that the minimum age for enrolment is 25 years old, and the maximum allowed age is 65."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Florida
Oregon
Other
How old are they?
65+
18 - 65
What site did they apply to?
Missouri Orthopaedic Institute
Other
Oregon Health and Science University
Jameson Crane Sports Medicine Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
What questions have other patients asked about this trial?
What is the timeline for this trial?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I have osteoarthritis on the outside of my right knee due to 2 acl surgeries and the lack of meniscus.
PatientReceived 1 prior treatment
I have had knee arthritis for more than 12 years. I have had Euflexxa shots for many years. They are not working anymore. I need to try something new. Also I don't want TKR. Thanks.
PatientReceived no prior treatments
I’ve been following the Calypso system and want to be part of the trial rather than having knee replacement surgery. I am active and stopped playing baseball due to osteoporosis on my inner right knee.
PatientReceived no prior treatments
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