Osteoarthritis, Hip Clinical Trial
Official title:
KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
There is a growing interest in the effects of mental health and wellness on orthopedic intervention outcomes, not only in terms of how advances in surgical procedures influence patient outcomes, but also with regard for physician physical and mental well-being. Although total hip arthroplasty (THA) is associated with favorable clinical outcomes as assessed by surgeon evaluation, radiographic analysis and implant longevity, unfavorable long-term pain and quality of life outcomes are consistently observed in upwards of 20% of patients receiving THAs. As such, the need to understand and address the determinants of positive and negative outcomes is of critical importance if the field hopes to continue to advance strategies to improve long-term outcomes for joint replacement. The overarching goal of this application is to assess the benefits of the KINCISE for patient recovery outcomes related to physical and mental well-being.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2024 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Male and female participants over age 21 with a compatible smartphone (Apple iPhone 6s or newer running iOS 13 or higher) are eligible to participate. - Participants must be community ambulatory Exclusion Criteria: - Age less than 21. - Incompatible smartphone device. - History of neurological injury or pathology. - Prior total joint athroplasty in the preceding year. |
Country | Name | City | State |
---|---|---|---|
United States | Univrsity of Cincinnati Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati |
United States,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Short Form (36) Health Survey | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | 1 year | |
Secondary | The Patient Health Questionnaire20 (PHQ-9) | Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. | 1 year |
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