Knee Osteoarthritis
Conditions
Keywords
Total Knee Replacement, Lower Quarter Y-Balance Test, Functional Outcomes, Patient Reported Outcomes
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | 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. |
| Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement. | 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. |
| Timed Get up and go | 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. |
| Sit to Stand Time | 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. |
| University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement. | 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. | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
60 patients signed consent form but 12 were withdrawn at the time of surgery because they required a different implant not included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Stryker Subjects will be receiving the Stryker Triathlon total knee replacement
Stryker | 25 |
| Zimmer Subjects will be receiving a Zimmer NexGen total knee replacement
Zimmer | 23 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incorrect Randomization procedure | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 2 |
Baseline characteristics
| Characteristic | Stryker | Zimmer | Total |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 8 | 63.1 years STANDARD_DEVIATION 7.3 | 62.5 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 25 participants | 23 participants | 48 participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 1 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
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.
Time frame: Baseline (Pre-Operative) to 52 weeks following total knee replacement
Population: Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement | YBT-LQ Composite Pre-Operative | 79.45 % of limb length | Standard Deviation 10.46 |
| Stryker | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement | YBT-LQ Composite Post-Op 52 Weeks | 70.44 % of limb length | Standard Deviation 9.31 |
| Zimmer | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement | YBT-LQ Composite Pre-Operative | 79.24 % of limb length | Standard Deviation 7.89 |
| Zimmer | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement | YBT-LQ Composite Post-Op 52 Weeks | 69.42 % of limb length | Standard Deviation 13.39 |
p-value: 0.856ANOVA
p-value: <0.001ANOVA
p-value: 0.822ANOVA
Primary
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.
Time frame: Baseline (Pre-Operative) to 6 weeks following total knee replacement
Population: Only subjects that were able to complete all of the YBT assessments at 6 weeks post total knee replacement were included in the analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement | YBT-LQ Composite Pre-Operative | 69.98 % of limb length | Standard Deviation 8.18 |
| Stryker | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement | YBT-LQ Composite 6 weeks | 73.25 % of limb length | Standard Deviation 7.95 |
| Zimmer | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement | YBT-LQ Composite Pre-Operative | 67.52 % of limb length | Standard Deviation 12.22 |
| Zimmer | Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement | YBT-LQ Composite 6 weeks | 73.32 % of limb length | Standard Deviation 9.15 |
p-value: 0.661ANOVA
p-value: <0.001ANOVA
p-value: 0.27ANOVA
Secondary
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.
Time frame: Baseline and 52 weeks following total knee replacement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. | Walking Speed Pre-Operative | 1.22 miles per hour | Standard Deviation 0.21 |
| Stryker | Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. | Walking Speed Post-Op 52 Weeks | 1.41 miles per hour | Standard Deviation 0.23 |
| Zimmer | Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. | Walking Speed Pre-Operative | 1.16 miles per hour | Standard Deviation 0.28 |
| Zimmer | Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. | Walking Speed Post-Op 52 Weeks | 1.28 miles per hour | Standard Deviation 0.23 |
p-value: 0.158ANOVA
p-value: <0.001ANOVA
p-value: 0.365ANOVA
Secondary
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.
Time frame: 6 weeks following total knee replacement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stryker | Walking Speed at 6 Weeks Following Total Knee Replacement. | 1.21 miles per hour | Standard Deviation 0.28 |
| Zimmer | Walking Speed at 6 Weeks Following Total Knee Replacement. | 1.19 miles per hour | Standard Deviation 0.22 |
Other Pre-specified
Change in Forgotten Joint Score (FJS) From 6 Weeks to 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.
Time frame: 6 weeks and 52 weeks following total knee replacement
Population: Participants who completed the Forgotten Joint Score (FJS) at week 6 and week 52. Not all subjects completed the FJS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement. | FJS, at 6 weeks | 69.63 units on a scale | Standard Deviation 20.9 |
| Stryker | Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement. | FJS, at 52 weeks | 37.7 units on a scale | Standard Deviation 21.4 |
| Zimmer | Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement. | FJS, at 6 weeks | 76.59 units on a scale | Standard Deviation 20.39 |
| Zimmer | Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement. | FJS, at 52 weeks | 30.8 units on a scale | Standard Deviation 29.6 |
p-value: 0.319t-test, 2 sided
Other Pre-specified
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 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.
Time frame: Baseline (Pre-Operative) and 52 weeks following total knee replacement
Population: Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement. | KOOS Total, Baseline Pre-Operative | 45.60 units on a scale | Standard Deviation 12.32 |
| Stryker | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement. | KOOS Total, Post-Op 52 week | 67.32 units on a scale | Standard Deviation 35.62 |
| Zimmer | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement. | KOOS Total, Baseline Pre-Operative | 46.08 units on a scale | Standard Deviation 13.5 |
| Zimmer | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement. | KOOS Total, Post-Op 52 week | 64.24 units on a scale | Standard Deviation 38.79 |
p-value: 0.83ANOVA
p-value: <0.001ANOVA
p-value: 0.728ANOVA
Other Pre-specified
Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 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.
Time frame: Baseline and 52 weeks following total knee replacement
Population: Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement. | UCLA Activity Pre-Operative | 4.19 units on a scale | Standard Deviation 1.33 |
| Stryker | Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement. | UCLA Activity Post-Op 52 Weeks | 5.90 units on a scale | Standard Deviation 1.55 |
| Zimmer | Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement. | UCLA Activity Pre-Operative | 3.83 units on a scale | Standard Deviation 1.38 |
| Zimmer | Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement. | UCLA Activity Post-Op 52 Weeks | 5.61 units on a scale | Standard Deviation 1.91 |
p-value: 0.416ANOVA
p-value: <0.001ANOVA
p-value: 0.917ANOVA
Other Pre-specified
Knee Society Score (KSS)
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
Population: Only 20 subjects in each arm completed the assessment at 1 year post-op.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Knee Society Score (KSS) | KSS Satsifaction, 6 weeks | 28.9 units on a scale | Standard Deviation 7.3 |
| Stryker | Knee Society Score (KSS) | KSS Functional Activity, 6 weeks | 60.8 units on a scale | Standard Deviation 18.1 |
| Stryker | Knee Society Score (KSS) | KSS Functional Activity, Baseline | 44.3 units on a scale | Standard Deviation 11.2 |
| Stryker | Knee Society Score (KSS) | KSS Functional Activity, 52 weeks Post-operative | 67.3 units on a scale | Standard Deviation 35.6 |
| Stryker | Knee Society Score (KSS) | KSS Satisfaction, Baseline Pre-Operatively | 11.1 units on a scale | Standard Deviation 5.2 |
| Zimmer | Knee Society Score (KSS) | KSS Functional Activity, 52 weeks Post-operative | 64.2 units on a scale | Standard Deviation 38.8 |
| Zimmer | Knee Society Score (KSS) | KSS Satisfaction, Baseline Pre-Operatively | 13.6 units on a scale | Standard Deviation 8.8 |
| Zimmer | Knee Society Score (KSS) | KSS Satsifaction, 6 weeks | 29.5 units on a scale | Standard Deviation 8.8 |
| Zimmer | Knee Society Score (KSS) | KSS Functional Activity, Baseline | 47.0 units on a scale | Standard Deviation 13.7 |
| Zimmer | Knee Society Score (KSS) | KSS Functional Activity, 6 weeks | 61.6 units on a scale | Standard Deviation 16.7 |
Other Pre-specified
Sit to Stand Time
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
Population: The 6 week time point was not used 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. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Sit to Stand Time | Sit to stand Pre-Operative | 3.90 Number of times | Standard Deviation 0.95 |
| Stryker | Sit to Stand Time | Sit to stand Post-Op 6 weeks | 4.5 Number of times | Standard Deviation 1.7 |
| Stryker | Sit to Stand Time | Sit to stand Post-Op 52 weeks | 5.40 Number of times | Standard Deviation 1.45 |
| Zimmer | Sit to Stand Time | Sit to stand Pre-Operative | 4.34 Number of times | Standard Deviation 1.34 |
| Zimmer | Sit to Stand Time | Sit to stand Post-Op 6 weeks | 4.6 Number of times | Standard Deviation 1.1 |
| Zimmer | Sit to Stand Time | Sit to stand Post-Op 52 weeks | 5.47 Number of times | Standard Deviation 1.81 |
Other Pre-specified
Timed Get up and go
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
Population: The 6 week time point was not used 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. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stryker | Timed Get up and go | Timed up and go Pre-Operative | 9.55 Seconds | Standard Deviation 3.86 |
| Stryker | Timed Get up and go | Timed up and go Post-Op 6 weeks | 9.38 Seconds | Standard Deviation 3.58 |
| Stryker | Timed Get up and go | Timed up and go Post-Op 52 weeks | 6.99 Seconds | Standard Deviation 1.8 |
| Zimmer | Timed Get up and go | Timed up and go Pre-Operative | 9.07 Seconds | Standard Deviation 2.48 |
| Zimmer | Timed Get up and go | Timed up and go Post-Op 6 weeks | 8.89 Seconds | Standard Deviation 1.89 |
| Zimmer | Timed Get up and go | Timed up and go Post-Op 52 weeks | 7.17 Seconds | Standard Deviation 1.39 |
Other Pre-specified
University of California, Los Angeles (UCLA) Activity Score at 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.
Time frame: 6 weeks following total knee replacement
Population: Only subjects who were able to complete the UCLA at six weeks were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stryker | University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement. | 4.48 units on a scale | Standard Deviation 1.42 |
| Zimmer | University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement. | 4.73 units on a scale | Standard Deviation 1.52 |