Total Knee Arthroplasty: Functional and Clinical Outcomes
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ClinicalTrials.gov Identifier: NCT01811563 |
Recruitment Status :
Completed
First Posted : March 14, 2013
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
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Condition or disease | Intervention/treatment | Phase |
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Knee Osteoarthritis | Device: Zimmer Device: Stryker | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | February 26, 2016 |
Actual Study Completion Date : | February 26, 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Stryker
Subjects will be receiving the Stryker Triathlon total knee replacement
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Device: Stryker |
Active Comparator: Zimmer
Subjects will be receiving a Zimmer NexGen total knee replacement
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Device: Zimmer |
- Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement [ Time Frame: Baseline (Pre-Operative) 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 [ Time Frame: Baseline (Pre-Operative) 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.
- Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. [ Time Frame: Baseline and 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. [ Time Frame: 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.
- Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement. [ Time Frame: Baseline and 52 weeks following total knee replacement ]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".
- University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement. [ Time Frame: 6 weeks following total knee replacement ]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".
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement. [ Time Frame: Baseline (Pre-Operative) and 52 weeks following total knee replacement ]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.
- Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement. [ Time Frame: 6 weeks and 52 weeks following total knee replacement ]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.
- Knee Society Score (KSS) [ Time Frame: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement ]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.
- Sit to Stand Time [ Time Frame: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement ]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.
- Timed Get up and go [ Time Frame: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement ]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.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811563
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Samuel S Wellman, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01811563 |
Other Study ID Numbers: |
Pro00043737 193447 ( Other Grant/Funding Number: Stryker ) |
First Posted: | March 14, 2013 Key Record Dates |
Results First Posted: | June 2, 2017 |
Last Update Posted: | June 2, 2017 |
Last Verified: | April 2017 |
Total Knee Replacement Lower Quarter Y-Balance Test Functional Outcomes Patient Reported Outcomes |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |