Stiffness Following Total Knee Arthroplasty
Conditions
Brief summary
Compare the outcome following manipulation under anesthesia for stiffness in a randomized controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time of manipulation to a control group receiving manipulation alone. Outcomes will include pain, range of motion, as well as subjective outcome scores.
Detailed description
Stiffness is a potential complication following Total Knee Arthroplasty (TKA). While a variety of factors have been cited as possible causes, such as component malrotation or improper soft-tissue balancing, however, an etiology is not always appreciated. Histologic and arthroscopic evidence of fibrosis suggests that an inflammatory process may contribute to loss of knee range of motion following surgery. Manipulation under anesthesia remains standard of care for stiffness following TKA. Manipulation shows improved range of motion for stiffness after total knee arthroplasty, however, patients do not always achieve full range of motion. Furthermore, repeat manipulation and manipulation greater than 8 weeks post-surgically have shown limited improvements. Given a possible role of the host inflammatory response and the importance of early gains in knee range of motion following total knee arthroplasty, limiting the inflammatory response at the time of manipulation may improve outcomes. Investigators would like to assess the role of anti-inflammatory medications to optimize range of motion and outcome for manipulation under anesthesia for stiffness following TKA.
Interventions
DRUGDexamethasone
8 mg of IV dexamethasone immediately before MUA.
DRUGCelecoxib
2 weeks per mouth of celecoxib (200 mg daily)
Sponsors
Knee Society
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis. 2. MUA's scheduled between 6-10 weeks postoperatively
Exclusion criteria
1. Intolerance to NSAIDs 2. Renal dysfunction 3. Age \< 18 or \> 90 years 4. Primary diagnosis of rheumatoid arthritis 5. Patients with a Glomerular Filtration Rate (GFR) \<60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Range of Motion After Manipulation Under Anesthesia | 6 weeks after manipulation | Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Functional Score | 6 weeks after the MUA, and 1 year after the MUA | The Knee Society Functional score was developed by the Knee Society as a method of evaluating how well a patient can use their joint. Knee function was evaluated in two categories: walking, and stair usage. Points range from 0-100. 0 = extreme problems, 100 = no problems. In each category, points range from 0-50, where 0 = extreme problems to 50 = no problems. Total scores are 0-100 with lower scores indicating extreme knee function problems and higher scores indicating no knee function problems. |
| Short Form Survey 12-item Version 2 (SF-12v2): Physical Health | 6 weeks after the MUA, and 1 year after the MUA | The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health. |
| Short Form Survey 12-item Version 2 (SF-12v2): Mental Health | 6 weeks after MUA, 1 Year after MUA | The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score | 6 weeks after the MUA, and 1 year after the MUA | The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score | 6 weeks after the MUA, and 1 year after the MUA | The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score | 6 weeks after MUA, 1 year after MUA | The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score | 6 weeks after MUA, 1 year after MUA | The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems. |
| Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life | 6 weeks after MUA, 1 year after MUA | The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems. |
| Knee Society Knee Score | 6 weeks after the MUA, and 1 year after the MUA | The Knee Society Knee Score is method of joint evaluation developed by the Knee Society to measure the condition of a patient's knee. Knee condition was evaluated in three categories: pain, range of motion, and stability. Points range from 0-100. 0 = extreme problems, 100 = no problems. Up to 50 points for pain, 25 points for range of motion, and 25 points for stability. Deductions occur for Extension lag, flexion contracture, malalignment, and pain at rest. |
| PROMIS-29 Outcome Form: Physical Function | 6 weeks after the MUA, and 1 year after the MUA | The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For physical function, higher scores indicate better function. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10. |
| PROMIS-29 Outcome Form: Anxiety | 6 weeks after MUA, and 1 year after MUA | The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For anxiety, lower scores indicate less anxiety. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10. |
| PROMIS-29 Outcome Form: Depression | 6 weeks after MUA, and 1 year after MUA | The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For depression, lower scores indicate fewer depressive symptoms. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10. |
| PROMIS-29 Outcome Form: Fatigue | 6 weeks after MUA, and 1 year after MUA | The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For fatigue, lower scores indicate less fatigue. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10. |
| PROMIS-29 Outcome Form: Sleep Disturbance | 6 weeks after MUA, and 1 year after MUA | The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For sleep disturbance, lower scores indicate less sleep disturbance. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10. |
| PROMIS-29 Outcome Form: Social Activities | 6 weeks after MUA, and 1 year after MUA | The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For social activities, higher scores indicate a better ability to participate in social roles and activities. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10. |
| PROMIS-29 Outcome Form: Pain Interference | 6 weeks after MUA, 1 year after MUA | The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For pain interference, higher scores indicate more frequent interference in activities due to pain. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR) | 6 weeks after the MUA, and 1 year after the MUA | KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities. Results are scored 0-100. 0 = extreme problems, 100 = no problems. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 16 orthopedic surgery centers across the United States. Enrollment took place between 2016 and 2021. The first patient was enrolled in October of 2016 and the final patient was enrolled in November of 2021.
Pre-assignment details
441 patients were screened for eligibility, 130 of which met inclusion criteria, were enrolled in the trial and had treatment randomization.
Participants by arm
| Arm | Count |
|---|---|
| MUA Alone Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. | 59 |
| MUA With Dexamethasone and Celecoxib For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
Dexamethasone: 8 mg of IV dexamethasone immediately before MUA.
Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily) | 71 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1 Year Post-MUA | Lost to Follow-up | 10 | 11 |
| 6 Weeks Post-MUA | Lost to Follow-up | 1 | 3 |
| 6 Weeks Post-MUA | Protocol Violation | 1 | 4 |
| 6 Weeks Post-MUA | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | MUA Alone | MUA With Dexamethasone and Celecoxib | Total |
|---|---|---|---|
| Age, Continuous | 61.6 Years STANDARD_DEVIATION 10.9 | 61.8 Years STANDARD_DEVIATION 8.4 | 61.7 Years STANDARD_DEVIATION 9.65 |
| ASA Status (n, %) I | 4 Participants | 5 Participants | 9 Participants |
| ASA Status (n, %) II | 39 Participants | 46 Participants | 85 Participants |
| ASA Status (n, %) III | 13 Participants | 17 Participants | 30 Participants |
| ASA Status (n, %) IV | 1 Participants | 0 Participants | 1 Participants |
| ASA Status (n, %) Unknown | 2 Participants | 3 Participants | 5 Participants |
| BMI (kg/m^2) | 31.4 Kilograms per meter-squared STANDARD_DEVIATION 5.6 | 32.2 Kilograms per meter-squared STANDARD_DEVIATION 6 | 31.8 Kilograms per meter-squared STANDARD_DEVIATION 5.8 |
| Height (cm) | 169.2 centimeters STANDARD_DEVIATION 10.4 | 166.6 centimeters STANDARD_DEVIATION 11 | 167.9 centimeters STANDARD_DEVIATION 10.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 34 Participants | 48 Participants | 82 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
| Weight (kg) | 90.0 kilograms STANDARD_DEVIATION 18 | 88.6 kilograms STANDARD_DEVIATION 19.6 | 89.3 kilograms STANDARD_DEVIATION 18.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 72 |
| other Total, other adverse events | 0 / 59 | 1 / 72 |
| serious Total, serious adverse events | 0 / 59 | 0 / 72 |
Outcome results
Primary
Knee Range of Motion After Manipulation Under Anesthesia
Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.
Time frame: 1 year from the date of the manipulation
Population: Patients who were able to complete a follow-up at the 1-year mark and have knee range of motion measured.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MUA Alone | Knee Range of Motion After Manipulation Under Anesthesia | 107.7 Degrees |
| MUA With Dexamethasone and Celecoxib | Knee Range of Motion After Manipulation Under Anesthesia | 107.6 Degrees |
Comparison: Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib.p-value: 0.81t-test, 2 sided
Primary
Knee Range of Motion After Manipulation Under Anesthesia
Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.
Time frame: 6 weeks after manipulation
Population: Patients who were able to complete follow-up and have range of motion measured.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MUA Alone | Knee Range of Motion After Manipulation Under Anesthesia | 98.7 Degrees |
| MUA With Dexamethasone and Celecoxib | Knee Range of Motion After Manipulation Under Anesthesia | 101.2 Degrees |
Comparison: Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib.p-value: 0.23t-test, 2 sided
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Time frame: 6 weeks after MUA, 1 year after MUA
Population: Patients who completed and returned the KOOS survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score | 6 weeks after MUA | 74.1 score on a scale | Standard Deviation 13.7 |
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score | 1 year after MUA | 81.0 score on a scale | Standard Deviation 18.1 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score | 6 weeks after MUA | 70.3 score on a scale | Standard Deviation 16.4 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score | 1 year after MUA | 76.6 score on a scale | Standard Deviation 20.6 |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)
KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Population: Patients who completed the KOOS JR survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR) | 6 weeks after MUA | 64.9 score on a scale | Standard Deviation 17.7 |
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR) | 1 year after MUA | 72.5 score on a scale | Standard Deviation 17 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR) | 6 weeks after MUA | 62.7 score on a scale | Standard Deviation 13.1 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR) | 1 year after MUA | 69.0 score on a scale | Standard Deviation 18.9 |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Population: Patients who completed the KOOS survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score | 6 weeks after MUA | 68.9 Score on a scale | Standard Deviation 20.3 |
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score | 1 year after MUA | 84.1 Score on a scale | Standard Deviation 10.7 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score | 6 weeks after MUA | 62.7 Score on a scale | Standard Deviation 18.1 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score | 1 year after MUA | 79.8 Score on a scale | Standard Deviation 17 |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Time frame: 6 weeks after MUA, 1 year after MUA
Population: Patients who completed the KOOS survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score | 6 weeks after MUA | 48.5 score on a scale | Standard Deviation 21 |
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score | 1 year after MUA | 61.0 score on a scale | Standard Deviation 25.3 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score | 6 weeks after MUA | 52.8 score on a scale | Standard Deviation 17.7 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score | 1 year after MUA | 62.2 score on a scale | Standard Deviation 19.8 |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Population: Patients who completed the KOOS questionnaire and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score | 6 weeks after MUA | 64.2 Score on a scale | Standard Deviation 22.4 |
| MUA Alone | Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score | 1 year after MUA | 82.5 Score on a scale | Standard Deviation 11 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score | 6 weeks after MUA | 58.0 Score on a scale | Standard Deviation 19.9 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score | 1 year after MUA | 75.7 Score on a scale | Standard Deviation 16 |
Secondary
Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life
The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Time frame: 6 weeks after MUA, 1 year after MUA
Population: Patients who completed the KOOS survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life | 6 weeks after MUA | 49.2 score on a scale | Standard Deviation 22.2 |
| MUA Alone | Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life | 1 year after MUA | 83.0 score on a scale | Standard Deviation 12.8 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life | 6 weeks after MUA | 50.0 score on a scale | Standard Deviation 22.8 |
| MUA With Dexamethasone and Celecoxib | Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life | 1 year after MUA | 67.1 score on a scale | Standard Deviation 27.2 |
Secondary
Knee Society Functional Score
The Knee Society Functional score was developed by the Knee Society as a method of evaluating how well a patient can use their joint. Knee function was evaluated in two categories: walking, and stair usage. Points range from 0-100. 0 = extreme problems, 100 = no problems. In each category, points range from 0-50, where 0 = extreme problems to 50 = no problems. Total scores are 0-100 with lower scores indicating extreme knee function problems and higher scores indicating no knee function problems.
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Population: Patients who were able to complete and return KSS Functional surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Society Functional Score | 1 year after MUA | 77.3 score on a 0-100 scale | Standard Deviation 24.9 |
| MUA Alone | Knee Society Functional Score | 6 weeks after MUA | 64.7 score on a 0-100 scale | Standard Deviation 22.5 |
| MUA With Dexamethasone and Celecoxib | Knee Society Functional Score | 6 weeks after MUA | 64.2 score on a 0-100 scale | Standard Deviation 19.2 |
| MUA With Dexamethasone and Celecoxib | Knee Society Functional Score | 1 year after MUA | 74.2 score on a 0-100 scale | Standard Deviation 20.8 |
Secondary
Knee Society Knee Score
The Knee Society Knee Score is method of joint evaluation developed by the Knee Society to measure the condition of a patient's knee. Knee condition was evaluated in three categories: pain, range of motion, and stability. Points range from 0-100. 0 = extreme problems, 100 = no problems. Up to 50 points for pain, 25 points for range of motion, and 25 points for stability. Deductions occur for Extension lag, flexion contracture, malalignment, and pain at rest.
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Population: Patients who were able to complete and return the KSS survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Knee Society Knee Score | 6 weeks after MUA | 65.1 Score on a 0-100 scale | Standard Deviation 17.6 |
| MUA Alone | Knee Society Knee Score | 1 year after MUA | 74.2 Score on a 0-100 scale | Standard Deviation 16.1 |
| MUA With Dexamethasone and Celecoxib | Knee Society Knee Score | 6 weeks after MUA | 66.8 Score on a 0-100 scale | Standard Deviation 16.9 |
| MUA With Dexamethasone and Celecoxib | Knee Society Knee Score | 1 year after MUA | 68.6 Score on a 0-100 scale | Standard Deviation 24.9 |
Secondary
PROMIS-29 Outcome Form: Anxiety
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For anxiety, lower scores indicate less anxiety. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Time frame: 6 weeks after MUA, and 1 year after MUA
Population: Patients who completed the PROMIS-29 survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | PROMIS-29 Outcome Form: Anxiety | 1 year after MUA | 43.6 t-score | Standard Deviation 6.1 |
| MUA Alone | PROMIS-29 Outcome Form: Anxiety | 6 weeks after MUA | 48.3 t-score | Standard Deviation 9.4 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Anxiety | 6 weeks after MUA | 48.9 t-score | Standard Deviation 9.4 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Anxiety | 1 year after MUA | 45.5 t-score | Standard Deviation 8.8 |
Secondary
PROMIS-29 Outcome Form: Depression
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For depression, lower scores indicate fewer depressive symptoms. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Time frame: 6 weeks after MUA, and 1 year after MUA
Population: Patients who completed the PROMIS-29 questionnaire and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | PROMIS-29 Outcome Form: Depression | 6 weeks after MUA | 46.6 t-score | Standard Deviation 9.4 |
| MUA Alone | PROMIS-29 Outcome Form: Depression | 1 year after MUA | 41.0 t-score | Standard Deviation 0 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Depression | 6 weeks after MUA | 48.7 t-score | Standard Deviation 8.6 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Depression | 1 year after MUA | 46.8 t-score | Standard Deviation 8.4 |
Secondary
PROMIS-29 Outcome Form: Fatigue
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For fatigue, lower scores indicate less fatigue. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Time frame: 6 weeks after MUA, and 1 year after MUA
Population: Patients who completed the PROMIS-29 survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | PROMIS-29 Outcome Form: Fatigue | 6 weeks after MUA | 46.6 t-score | Standard Deviation 8.7 |
| MUA Alone | PROMIS-29 Outcome Form: Fatigue | 1 year after MUA | 39.3 t-score | Standard Deviation 7.2 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Fatigue | 6 weeks after MUA | 48.2 t-score | Standard Deviation 8.5 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Fatigue | 1 year after MUA | 41.5 t-score | Standard Deviation 8.9 |
Secondary
PROMIS-29 Outcome Form: Pain Interference
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For pain interference, higher scores indicate more frequent interference in activities due to pain. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Time frame: 6 weeks after MUA, 1 year after MUA
Population: Patients who completed the PROMIS-29 survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | PROMIS-29 Outcome Form: Pain Interference | 6 weeks after MUA | 56.1 t-score | Standard Deviation 9.7 |
| MUA Alone | PROMIS-29 Outcome Form: Pain Interference | 1 year after MUA | 47.4 t-score | Standard Deviation 7.2 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Pain Interference | 6 weeks after MUA | 58.2 t-score | Standard Deviation 7.3 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Pain Interference | 1 year after MUA | 56.7 t-score | Standard Deviation 12.4 |
Secondary
PROMIS-29 Outcome Form: Physical Function
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For physical function, higher scores indicate better function. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Population: Patients who completed the PROMIS-29 survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | PROMIS-29 Outcome Form: Physical Function | 1 year after MUA | 52.2 t-score | Standard Deviation 6.2 |
| MUA Alone | PROMIS-29 Outcome Form: Physical Function | 6 weeks after MUA | 41.0 t-score | Standard Deviation 5.3 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Physical Function | 6 weeks after MUA | 42.5 t-score | Standard Deviation 8.4 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Physical Function | 1 year after MUA | 45.2 t-score | Standard Deviation 10.2 |
Secondary
PROMIS-29 Outcome Form: Sleep Disturbance
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For sleep disturbance, lower scores indicate less sleep disturbance. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Time frame: 6 weeks after MUA, and 1 year after MUA
Population: Patients who completed the PROMIS-29 survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | PROMIS-29 Outcome Form: Sleep Disturbance | 6 weeks after MUA | 54.7 t-score | Standard Deviation 9.7 |
| MUA Alone | PROMIS-29 Outcome Form: Sleep Disturbance | 1 year after MUA | 48.3 t-score | Standard Deviation 9.4 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Sleep Disturbance | 6 weeks after MUA | 57.4 t-score | Standard Deviation 8.6 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Sleep Disturbance | 1 year after MUA | 48.0 t-score | Standard Deviation 7.5 |
Secondary
PROMIS-29 Outcome Form: Social Activities
The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For social activities, higher scores indicate a better ability to participate in social roles and activities. Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.
Time frame: 6 weeks after MUA, and 1 year after MUA
Population: Patients who completed the PROMIS-29 survey and returned it.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | PROMIS-29 Outcome Form: Social Activities | 6 weeks after MUA | 49.2 t-score | Standard Deviation 8.2 |
| MUA Alone | PROMIS-29 Outcome Form: Social Activities | 1 year after MUA | 62.3 t-score | Standard Deviation 4.7 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Social Activities | 6 weeks after MUA | 51.5 t-score | Standard Deviation 9.2 |
| MUA With Dexamethasone and Celecoxib | PROMIS-29 Outcome Form: Social Activities | 1 year after MUA | 56.1 t-score | Standard Deviation 10.5 |
Secondary
Short Form Survey 12-item Version 2 (SF-12v2): Mental Health
The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health.
Time frame: 6 weeks after MUA, 1 Year after MUA
Population: Patients who completed and returned the SF-12 survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Short Form Survey 12-item Version 2 (SF-12v2): Mental Health | 6 weeks after MUA | 51.7 t-score | Standard Deviation 9.9 |
| MUA Alone | Short Form Survey 12-item Version 2 (SF-12v2): Mental Health | 1 year after MUA | 54.4 t-score | Standard Deviation 8.8 |
| MUA With Dexamethasone and Celecoxib | Short Form Survey 12-item Version 2 (SF-12v2): Mental Health | 6 weeks after MUA | 53.7 t-score | Standard Deviation 9.8 |
| MUA With Dexamethasone and Celecoxib | Short Form Survey 12-item Version 2 (SF-12v2): Mental Health | 1 year after MUA | 54.3 t-score | Standard Deviation 8.9 |
Secondary
Short Form Survey 12-item Version 2 (SF-12v2): Physical Health
The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health.
Time frame: 6 weeks after the MUA, and 1 year after the MUA
Population: Patients who were able to complete and return the Physical Health portion of the SF-12 survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MUA Alone | Short Form Survey 12-item Version 2 (SF-12v2): Physical Health | 6 weeks after MUA | 38.7 t-score | Standard Deviation 9.4 |
| MUA Alone | Short Form Survey 12-item Version 2 (SF-12v2): Physical Health | 1 year after MUA | 44.8 t-score | Standard Deviation 10.8 |
| MUA With Dexamethasone and Celecoxib | Short Form Survey 12-item Version 2 (SF-12v2): Physical Health | 1 year after MUA | 43.3 t-score | Standard Deviation 10.3 |
| MUA With Dexamethasone and Celecoxib | Short Form Survey 12-item Version 2 (SF-12v2): Physical Health | 6 weeks after MUA | 37.0 t-score | Standard Deviation 9.7 |