N/A
N=48
Total Knee Arthroplasty: Functional and Clinical Outcomes
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01811563 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement — 69.98; 67.52; 73.25; 73.32 % of limb length — p=0.661
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zimmer (Device); Stryker (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement |
69.98; 67.52; 73.25; 73.32 | 0.661 |
| PRIMARY Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement |
79.45; 79.24; 70.44; 69.42 | 0.856 |
| SECONDARY Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. |
1.22; 1.16; 1.41; 1.28 | .158 |
| SECONDARY Walking Speed at 6 Weeks Following Total Knee Replacement. |
1.21; 1.19 | — |
Summary
The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.
Eligibility Criteria
Inclusion Criteria
- Patients requiring primary total knee replacement
- Patients willing and able to comply with the follow-up visits and evaluations
- Patients willing to sign informed consent approved by the Institutional Review Board
Exclusion Criteria
- Patients with inflammatory arthritis
- Patients with diabetic neuropathy
- Patients unable to ambulate without the use of an assistive device prior to surgery
- Patients unable to stand in single limb stance on each foot prior to surgery.
Data sourced from ClinicalTrials.gov (NCT01811563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.