KineSpring® System Patient Preference Study
March 7, 2019 updated by: Moximed
The primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the KineSpring System.
Study Overview
Detailed Description
Well-established, quantitative research methods were employed to understand the relative importance of effectiveness, safety, and other characteristics of orthopedic surgical treatments and develop a benefit-risk model to inform regulatory decision making.
Study Type
Observational
Enrollment (Actual)
323
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Males and females aged 25 to 80 years old diagnosed with osteoarthritis in the knee
Description
Inclusion Criteria:
- Males and females aged 25 - 80 years
- Diagnosed with osteoarthritis in the knee
- Experience pain in the knee of greater than or equal to a "4" on a "0 - 10" scale, where 0 means not at all painful and 10 means extremely painful
- Experience knee pain at least once a week
- Previously failed non-surgical treatments for knee OA pain
- Pass a security screen
Exclusion Criteria:
- Do not suffer or has not been diagnosed with knee osteoarthritis
- Has had knee surgical intervention involving an implant or a prosthesis (i.e. total knee replacement, unicompartmental knee arthroplasty, high tibial osteotomy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient preferences for knee osteoarthritis surgical procedures
Time Frame: At time of survey
|
Patient preference for knee osteoarthritis surgeries
|
At time of survey
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tessa Yamut, Moximed
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
October 13, 2016
First Submitted That Met QC Criteria
October 13, 2016
First Posted (Estimate)
October 17, 2016
Study Record Updates
Last Update Posted (Actual)
March 11, 2019
Last Update Submitted That Met QC Criteria
March 7, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102392
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.