Clinical trial NCT01811563: Total Knee Arthroplasty: Functional and Clinical Outcomes
Official title: Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Replacement
Lower Quarter Y-Balance Test
Functional Outcomes
Patient Reported Outcomes
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.

Eligibility criteria: Inclusion Criteria:

1. Patients requiring primary total knee replacement
2. Patients willing and able to comply with the follow-up visits and evaluations
3. Patients willing to sign informed consent approved by the Institutional Review Board

Exclusion Criteria:

1. Patients with inflammatory arthritis
2. Patients with diabetic neuropathy
3. Patients unable to ambulate without the use of an assistive device prior to surgery
4. Patients unable to stand in single limb stance on each foot prior to surgery.

Primary outcomes:
measure: Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
timeFrame: Baseline (Pre-Operative) to 6 weeks following total knee replacement
measure: Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
timeFrame: Baseline (Pre-Operative) to 52 weeks following total knee replacement
Secondary outcomes:
measure: Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
timeFrame: Baseline and 52 weeks following total knee replacement
measure: Walking Speed at 6 Weeks Following Total Knee Replacement.
timeFrame: 6 weeks following total knee replacement
Other outcomes:
measure: Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
timeFrame: Baseline and 52 weeks following total knee replacement
measure: University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
timeFrame: 6 weeks following total knee replacement
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
timeFrame: Baseline (Pre-Operative) and 52 weeks following total knee replacement
measure: Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
timeFrame: 6 weeks and 52 weeks following total knee replacement
measure: Knee Society Score (KSS)
timeFrame: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
measure: Sit to Stand Time
timeFrame: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
measure: Timed Get up and go
timeFrame: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Samuel S Wellman, MD
role: PRINCIPAL_INVESTIGATOR
References: