KineSpring® System Patient Preference Study

Osteoarthritis of the Knee Clinical Trial

Official title:

KineSpring® System Patient Preference Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934672
• Other study ID #: 102392
• Status: Completed
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: March 2019
• Source: Moximed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• Survey
Internet panelists, who self-reported that they or another adult in their household has osteoarthritis, were sent an email invitation to the survey site.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moximed

References & Publications (1)

Moorman CT 3rd, Kirwan T, Share J, Vannabouathong C. Patient Preferences Regarding Surgical Interventions for Knee Osteoarthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Sep 20;10:1179544117732039. doi: 10.1177/1179544117732039. eCollectio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient preferences for knee osteoarthritis surgical procedures	Patient preference for knee osteoarthritis surgeries	At time of survey