KineSpring® System Patient Preference Study

Moximed

Status: Completed

Conditions: Osteoarthritis of the Knee

Treatments: Other: Survey

Study type: Observational

Funder types: Industry

Identifiers

NCT02934672

102392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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)