Quality of Life Clinical Trial
Official title:
Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - Primary gonarthrosis - planned TKA or UKA - adequate cognitive and lingual competence - informed consent Exclusion Criteria: - TKA or UKA revision - Surgery after trauma - Rheumatic disease - Neurologic disease - previous arthroplasty of the lower extremity (<9 months) - cardiovascular disease - restricted weight bearing of the lower extremity after surgery |
Country | Name | City | State |
---|---|---|---|
Austria | Kepler University Hospital | Linz |
Lead Sponsor | Collaborator |
---|---|
Johannes Kepler University of Linz | Kepler University Hospital |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Center of pressure track (COPT) | Posturographic Parameter | Before surgery | |
Primary | Center of pressure track (COPT) | Posturographic Parameter | Day 3-7 after surgery | |
Primary | Center of pressure track (COPT) | Posturographic Parameter | 3 months after surgery | |
Primary | Center of pressure track (COPT) | Posturographic Parameter | 1 year after surgery | |
Secondary | Functional reach test | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | ||
Secondary | Timed up and go - test | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | ||
Secondary | Knee Injury and Osteoarthritis Outcome Score | Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | EQ-5D - Score | Scale: Points, Minimum: 1, Maximum: <0, higher score means better outcome | Before surgery; 1 year after surgery | |
Secondary | 10 m Walking test | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | ||
Secondary | WOMAC Score | Scale: Points, Minimum: 0, Maximum: 240, higher score means worse outcome | Before surgery; 1 year after surgery, higher score means better outcome | |
Secondary | Forgotten Joint Score | Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome | Before surgery; 1 year after surgery | |
Secondary | Oxford Knee Score | Scale: Points, Minimum: 12, Maximum: 60, higher score means worse outcome | Before surgery; 1 year after surgery | |
Secondary | Knee Society Score | Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome | Before surgery; 1 year after surgery | |
Secondary | The University of California at Los Angeles Activity Score | Scale: Points, Minimum: 1, Maximum: 10, higher score means better outcome | Before surgery; 1 year after surgery | |
Secondary | Area of Sway | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | Frequency of Sway | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | Harmony Index | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | Stability energy | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | Movement control | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | Feedback (visual, somatosensoric, vestibular) | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | Weight Distribution Index | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery | |
Secondary | Fulfillment of Tests | Posturographic Parameter | Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery |
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