Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 193447 | Other Grant/Funding Number | Stryker |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stryker | Active Comparator | Subjects will be receiving the Stryker Triathlon total knee replacement |
|
| Zimmer | Active Comparator | Subjects will be receiving a Zimmer NexGen total knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer | Device |
| ||
| Stryker |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Pre-Operative) to 6 weeks following total knee replacement |
| 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. | Baseline (Pre-Operative) to 52 weeks following total knee replacement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 52 weeks following total knee replacement |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Baseline and 52 weeks following total knee replacement |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samuel S Wellman, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stryker | Subjects will be receiving the Stryker Triathlon total knee replacement Stryker |
| FG001 | Zimmer | Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stryker | Subjects will be receiving the Stryker Triathlon total knee replacement Stryker |
| BG001 | Zimmer | Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only subjects that were able to complete all of the YBT assessments at 6 weeks post total knee replacement were included in the analyses. | Posted | Mean | Standard Deviation | % of limb length | Baseline (Pre-Operative) to 6 weeks following total knee replacement |
|
52 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stryker | Subjects will be receiving the Stryker Triathlon total knee replacement Stryker |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient fell while completeing the 6 weeks testing | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient was being tested at the 6 week post-op time point in the clinic and was asked to complete the single leg stance test as part of the functional assessments that were to be completed at this study visit. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel Wellman, MD | Duke University Medical Center | 919-681-4055 | samuel.wellman@duke.edu |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 6 weeks following total knee replacement |
| 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". | 6 weeks following total knee replacement |
| 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. | Baseline (Pre-Operative) and 52 weeks following total knee replacement |
| 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. | 6 weeks and 52 weeks following total knee replacement |
| 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. | Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement |
| 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. | Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement |
| 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. | Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects will be receiving the Stryker Triathlon total knee replacement Stryker |
| OG001 | Zimmer | Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | % of limb length | Baseline (Pre-Operative) to 52 weeks following total knee replacement |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | miles per hour | Baseline and 52 weeks following total knee replacement |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | miles per hour | 6 weeks following total knee replacement |
|
|
|
| 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". | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 52 weeks following total knee replacement |
|
|
|
|
| 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". | Only subjects who were able to complete the UCLA at six weeks were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks following total knee replacement |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-Operative) and 52 weeks following total knee replacement |
|
|
|
|
| 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. | Participants who completed the Forgotten Joint Score (FJS) at week 6 and week 52. Not all subjects completed the FJS. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks and 52 weeks following total knee replacement |
|
|
|
|
| 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. | Only 20 subjects in each arm completed the assessment at 1 year post-op. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | Number of times | Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | Seconds | Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | Zimmer | Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer | 0 | 23 | 0 | 23 | 0 | 23 |
|
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| <0.001 |
| Equivalence |
Time independent of implant, Baseline to 52 Weeks |
| ANOVA | 0.822 | Equivalence | Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker |
| Equivalence |
Main effect for time, Baseline to 52 weeks |
| ANOVA | 0.365 | Equivalence | Interaction of time by implant, Baseline to 52 weeks |
| Equivalence |
Main effect for time, Baseline to 52 weeks |
| ANOVA | 0.917 | Equivalence | Implant by time interaction, baseline to 52 weeks |
| Equivalence |
Main effect by time, baseline to 52 weeks |
| ANOVA | 0.728 | Equivalence | Interaction between implant and time, baseline to 52 weeks |
| FJS, at 52 weeks |
|
|
| KSS Satsifaction, 6 weeks |
|
|
| KSS Functional Activity, Baseline |
|
|
| KSS Functional Activity, 6 weeks |
|
|
| KSS Functional Activity, 52 weeks Post-operative |
|
|
| Sit to stand Post-Op 6 weeks |
|
|
| Sit to stand Post-Op 52 weeks |
|
|
| Timed up and go Post-Op 6 weeks |
|
|
| Timed up and go Post-Op 52 weeks |
|
|