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Total Knee Arthroplasty: Functional and Clinical Outcomes

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zimmer
Stryker
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Total Knee Replacement, Lower Quarter Y-Balance Test, Functional Outcomes, Patient Reported Outcomes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stryker

Zimmer

Arm Description

Subjects will be receiving the Stryker Triathlon total knee replacement

Subjects will be receiving a Zimmer NexGen total knee replacement

Outcomes

Primary Outcome Measures

Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.

Secondary Outcome Measures

Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
Walking Speed at 6 Weeks Following Total Knee Replacement.
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.

Full Information

First Posted
March 12, 2013
Last Updated
April 28, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01811563
Brief Title
Total Knee Arthroplasty: Functional and Clinical Outcomes
Official Title
Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 26, 2016 (Actual)
Study Completion Date
February 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total Knee Replacement, Lower Quarter Y-Balance Test, Functional Outcomes, Patient Reported Outcomes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stryker
Arm Type
Active Comparator
Arm Description
Subjects will be receiving the Stryker Triathlon total knee replacement
Arm Title
Zimmer
Arm Type
Active Comparator
Arm Description
Subjects will be receiving a Zimmer NexGen total knee replacement
Intervention Type
Device
Intervention Name(s)
Zimmer
Intervention Type
Device
Intervention Name(s)
Stryker
Primary Outcome Measure Information:
Title
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
Description
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Time Frame
Baseline (Pre-Operative) to 6 weeks following total knee replacement
Title
Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
Description
The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Time Frame
Baseline (Pre-Operative) to 52 weeks following total knee replacement
Secondary Outcome Measure Information:
Title
Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
Description
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
Time Frame
Baseline and 52 weeks following total knee replacement
Title
Walking Speed at 6 Weeks Following Total Knee Replacement.
Description
Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
Time Frame
6 weeks following total knee replacement
Other Pre-specified Outcome Measures:
Title
Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
Description
The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
Time Frame
Baseline and 52 weeks following total knee replacement
Title
University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
Description
The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
Time Frame
6 weeks following total knee replacement
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
Description
The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time Frame
Baseline (Pre-Operative) and 52 weeks following total knee replacement
Title
Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
Description
The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.
Time Frame
6 weeks and 52 weeks following total knee replacement
Title
Knee Society Score (KSS)
Description
The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.
Time Frame
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
Title
Sit to Stand Time
Description
The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.
Time Frame
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
Title
Timed Get up and go
Description
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
Time Frame
Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel S Wellman, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Total Knee Arthroplasty: Functional and Clinical Outcomes

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