Trial Outcomes & Findings for MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty (NCT NCT02739035)

NCT ID: NCT02739035

Last Updated: 2023-11-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 130 participants
• Primary outcome timeframe: 6 weeks after manipulation
• Results posted on: 2023-11-21

Participant Flow

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.

441 patients were screened for eligibility, 130 of which met inclusion criteria, were enrolled in the trial and had treatment randomization.

Participant milestones

Measure	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.	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)
6 Weeks Post-MUA STARTED	59	71
6 Weeks Post-MUA COMPLETED	56	61
6 Weeks Post-MUA NOT COMPLETED	3	10
1 Year Post-MUA STARTED	56	61
1 Year Post-MUA COMPLETED	46	50
1 Year Post-MUA NOT COMPLETED	10	11

Reasons for withdrawal

Measure	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.	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)
6 Weeks Post-MUA Withdrawal by Subject	1	3
6 Weeks Post-MUA Lost to Follow-up	1	3
6 Weeks Post-MUA Protocol Violation	1	4
1 Year Post-MUA Lost to Follow-up	10	11

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	MUA Alone n=59 Participants 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.	MUA With Dexamethasone and Celecoxib n=71 Participants 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)	Total n=130 Participants Total of all reporting groups
Age, Continuous	61.6 Years STANDARD_DEVIATION 10.9 • n=59 Participants	61.8 Years STANDARD_DEVIATION 8.4 • n=71 Participants	61.7 Years STANDARD_DEVIATION 9.65 • n=130 Participants
Sex: Female, Male Female	34 Participants n=59 Participants	48 Participants n=71 Participants	82 Participants n=130 Participants
Sex: Female, Male Male	25 Participants n=59 Participants	23 Participants n=71 Participants	48 Participants n=130 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight (kg)	90.0 kilograms STANDARD_DEVIATION 18.0 • n=59 Participants	88.6 kilograms STANDARD_DEVIATION 19.6 • n=71 Participants	89.3 kilograms STANDARD_DEVIATION 18.8 • n=130 Participants
Height (cm)	169.2 centimeters STANDARD_DEVIATION 10.4 • n=59 Participants	166.6 centimeters STANDARD_DEVIATION 11.0 • n=71 Participants	167.9 centimeters STANDARD_DEVIATION 10.7 • n=130 Participants
BMI (kg/m^2)	31.4 Kilograms per meter-squared STANDARD_DEVIATION 5.6 • n=59 Participants	32.2 Kilograms per meter-squared STANDARD_DEVIATION 6.0 • n=71 Participants	31.8 Kilograms per meter-squared STANDARD_DEVIATION 5.8 • n=130 Participants
ASA Status (n, %) I	4 Participants n=59 Participants	5 Participants n=71 Participants	9 Participants n=130 Participants
ASA Status (n, %) II	39 Participants n=59 Participants	46 Participants n=71 Participants	85 Participants n=130 Participants
ASA Status (n, %) III	13 Participants n=59 Participants	17 Participants n=71 Participants	30 Participants n=130 Participants
ASA Status (n, %) IV	1 Participants n=59 Participants	0 Participants n=71 Participants	1 Participants n=130 Participants
ASA Status (n, %) Unknown	2 Participants n=59 Participants	3 Participants n=71 Participants	5 Participants n=130 Participants

PRIMARY outcome

Timeframe: 6 weeks after manipulation

Population: Patients who were able to complete follow-up and have range of motion measured.

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.

Outcome measures

Measure	MUA Alone n=53 Participants 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.	MUA With Dexamethasone and Celecoxib n=58 Participants 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)
Knee Range of Motion After Manipulation Under Anesthesia	98.7 Degrees Interval 60.0 to 125.0	101.2 Degrees Interval 75.0 to 124.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MUA Alone n=38 Participants 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.	MUA With Dexamethasone and Celecoxib n=45 Participants 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)
Knee Range of Motion After Manipulation Under Anesthesia	107.7 Degrees Interval 54.0 to 135.0	107.6 Degrees Interval 70.0 to 130.0

SECONDARY outcome

Timeframe: 6 weeks after the MUA, and 1 year after the MUA

Population: Patients who were able to complete and return KSS Functional surveys.

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.

Outcome measures

Measure	MUA Alone n=53 Participants 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.	MUA With Dexamethasone and Celecoxib n=59 Participants 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)
Knee Society Functional Score 6 weeks after MUA	64.7 score on a 0-100 scale Standard Deviation 22.5	64.2 score on a 0-100 scale Standard Deviation 19.2
Knee Society Functional Score 1 year after MUA	77.3 score on a 0-100 scale Standard Deviation 24.9	74.2 score on a 0-100 scale Standard Deviation 20.8

SECONDARY outcome

Timeframe: 6 weeks after the MUA, and 1 year after the MUA

Population: Patients who were able to complete and return the KSS survey.

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.

Outcome measures

Measure	MUA Alone n=52 Participants 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.	MUA With Dexamethasone and Celecoxib n=58 Participants 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)
Knee Society Knee Score 6 weeks after MUA	65.1 Score on a 0-100 scale Standard Deviation 17.6	66.8 Score on a 0-100 scale Standard Deviation 16.9
Knee Society Knee Score 1 year after MUA	74.2 Score on a 0-100 scale Standard Deviation 16.1	68.6 Score on a 0-100 scale Standard Deviation 24.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MUA Alone n=54 Participants 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.	MUA With Dexamethasone and Celecoxib n=60 Participants 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)
Short Form Survey 12-item Version 2 (SF-12v2): Physical Health 6 weeks after MUA	38.7 t-score Standard Deviation 9.4	37.0 t-score Standard Deviation 9.7
Short Form Survey 12-item Version 2 (SF-12v2): Physical Health 1 year after MUA	44.8 t-score Standard Deviation 10.8	43.3 t-score Standard Deviation 10.3

SECONDARY outcome

Timeframe: 6 weeks after MUA, 1 Year after MUA

Population: Patients who completed and returned the SF-12 survey.

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.

Outcome measures

Measure	MUA Alone n=54 Participants 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.	MUA With Dexamethasone and Celecoxib n=60 Participants 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)
Short Form Survey 12-item Version 2 (SF-12v2): Mental Health 6 weeks after MUA	51.7 t-score Standard Deviation 9.9	53.7 t-score Standard Deviation 9.8
Short Form Survey 12-item Version 2 (SF-12v2): Mental Health 1 year after MUA	54.4 t-score Standard Deviation 8.8	54.3 t-score Standard Deviation 8.9

SECONDARY outcome

Timeframe: 6 weeks after the MUA, and 1 year after the MUA

Population: Patients who completed the KOOS questionnaire and returned it.

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.

Outcome measures

Measure	MUA Alone n=16 Participants 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.	MUA With Dexamethasone and Celecoxib n=17 Participants 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)
Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score 6 weeks after MUA	64.2 Score on a scale Standard Deviation 22.4	58.0 Score on a scale Standard Deviation 19.9
Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score 1 year after MUA	82.5 Score on a scale Standard Deviation 11.0	75.7 Score on a scale Standard Deviation 16.0

SECONDARY outcome

Timeframe: 6 weeks after the MUA, and 1 year after the MUA

Population: Patients who completed the KOOS survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=17 Participants 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.	MUA With Dexamethasone and Celecoxib n=17 Participants 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)
Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score 6 weeks after MUA	68.9 Score on a scale Standard Deviation 20.3	62.7 Score on a scale Standard Deviation 18.1
Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score 1 year after MUA	84.1 Score on a scale Standard Deviation 10.7	79.8 Score on a scale Standard Deviation 17.0

SECONDARY outcome

Timeframe: 6 weeks after MUA, 1 year after MUA

Population: Patients who completed and returned the KOOS survey.

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.

Outcome measures

Measure	MUA Alone n=16 Participants 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.	MUA With Dexamethasone and Celecoxib n=17 Participants 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)
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	70.3 score on a scale Standard Deviation 16.4
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	76.6 score on a scale Standard Deviation 20.6

SECONDARY outcome

Timeframe: 6 weeks after MUA, 1 year after MUA

Population: Patients who completed the KOOS survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=8 Participants 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.	MUA With Dexamethasone and Celecoxib n=10 Participants 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)
Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score 6 weeks after MUA	48.5 score on a scale Standard Deviation 21.0	52.8 score on a scale Standard Deviation 17.7
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	62.2 score on a scale Standard Deviation 19.8

SECONDARY outcome

Timeframe: 6 weeks after MUA, 1 year after MUA

Population: Patients who completed the KOOS survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=16 Participants 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.	MUA With Dexamethasone and Celecoxib n=17 Participants 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)
Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life 6 weeks after MUA	49.2 score on a scale Standard Deviation 22.2	50.0 score on a scale Standard Deviation 22.8
Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life 1 year after MUA	83.0 score on a scale Standard Deviation 12.8	67.1 score on a scale Standard Deviation 27.2

SECONDARY outcome

Timeframe: 6 weeks after the MUA, and 1 year after the MUA

Population: Patients who completed the KOOS JR survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=44 Participants 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.	MUA With Dexamethasone and Celecoxib n=53 Participants 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)
Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR) 1 year after MUA	72.5 score on a scale Standard Deviation 17.0	69.0 score on a scale Standard Deviation 18.9
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	62.7 score on a scale Standard Deviation 13.1

SECONDARY outcome

Timeframe: 6 weeks after the MUA, and 1 year after the MUA

Population: Patients who completed the PROMIS-29 survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=14 Participants 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.	MUA With Dexamethasone and Celecoxib n=13 Participants 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)
PROMIS-29 Outcome Form: Physical Function 6 weeks after MUA	41.0 t-score Standard Deviation 5.3	42.5 t-score Standard Deviation 8.4
PROMIS-29 Outcome Form: Physical Function 1 year after MUA	52.2 t-score Standard Deviation 6.2	45.2 t-score Standard Deviation 10.2

SECONDARY outcome

Timeframe: 6 weeks after MUA, and 1 year after MUA

Population: Patients who completed the PROMIS-29 survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=14 Participants 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.	MUA With Dexamethasone and Celecoxib n=13 Participants 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)
PROMIS-29 Outcome Form: Anxiety 6 weeks after MUA	48.3 t-score Standard Deviation 9.4	48.9 t-score Standard Deviation 9.4
PROMIS-29 Outcome Form: Anxiety 1 year after MUA	43.6 t-score Standard Deviation 6.1	45.5 t-score Standard Deviation 8.8

SECONDARY outcome

Timeframe: 6 weeks after MUA, and 1 year after MUA

Population: Patients who completed the PROMIS-29 questionnaire and returned it.

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.

Outcome measures

Measure	MUA Alone n=13 Participants 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.	MUA With Dexamethasone and Celecoxib n=13 Participants 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)
PROMIS-29 Outcome Form: Depression 6 weeks after MUA	46.6 t-score Standard Deviation 9.4	48.7 t-score Standard Deviation 8.6
PROMIS-29 Outcome Form: Depression 1 year after MUA	41.0 t-score Standard Deviation 0	46.8 t-score Standard Deviation 8.4

SECONDARY outcome

Timeframe: 6 weeks after MUA, and 1 year after MUA

Population: Patients who completed the PROMIS-29 survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=14 Participants 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.	MUA With Dexamethasone and Celecoxib n=13 Participants 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)
PROMIS-29 Outcome Form: Fatigue 6 weeks after MUA	46.6 t-score Standard Deviation 8.7	48.2 t-score Standard Deviation 8.5
PROMIS-29 Outcome Form: Fatigue 1 year after MUA	39.3 t-score Standard Deviation 7.2	41.5 t-score Standard Deviation 8.9

SECONDARY outcome

Timeframe: 6 weeks after MUA, and 1 year after MUA

Population: Patients who completed the PROMIS-29 survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=14 Participants 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.	MUA With Dexamethasone and Celecoxib n=13 Participants 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)
PROMIS-29 Outcome Form: Sleep Disturbance 1 year after MUA	48.3 t-score Standard Deviation 9.4	48.0 t-score Standard Deviation 7.5
PROMIS-29 Outcome Form: Sleep Disturbance 6 weeks after MUA	54.7 t-score Standard Deviation 9.7	57.4 t-score Standard Deviation 8.6

SECONDARY outcome

Timeframe: 6 weeks after MUA, and 1 year after MUA

Population: Patients who completed the PROMIS-29 survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=14 Participants 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.	MUA With Dexamethasone and Celecoxib n=13 Participants 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)
PROMIS-29 Outcome Form: Social Activities 6 weeks after MUA	49.2 t-score Standard Deviation 8.2	51.5 t-score Standard Deviation 9.2
PROMIS-29 Outcome Form: Social Activities 1 year after MUA	62.3 t-score Standard Deviation 4.7	56.1 t-score Standard Deviation 10.5

SECONDARY outcome

Timeframe: 6 weeks after MUA, 1 year after MUA

Population: Patients who completed the PROMIS-29 survey and returned it.

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.

Outcome measures

Measure	MUA Alone n=14 Participants 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.	MUA With Dexamethasone and Celecoxib n=12 Participants 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)
PROMIS-29 Outcome Form: Pain Interference 6 weeks after MUA	56.1 t-score Standard Deviation 9.7	58.2 t-score Standard Deviation 7.3
PROMIS-29 Outcome Form: Pain Interference 1 year after MUA	47.4 t-score Standard Deviation 7.2	56.7 t-score Standard Deviation 12.4

Adverse Events

MUA Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MUA With Dexamethasone and Celecoxib

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MUA Alone n=59 participants at risk 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.	MUA With Dexamethasone and Celecoxib n=72 participants at risk 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)
Injury, poisoning and procedural complications Head Injury	0.00% 0/59 • Adverse events were monitored throughout the study from the beginning of enrollment until both the 6-months post-manipulation under anesthesia and 1-year post-manipulation under anesthesia timepoints had been reached. Approximately 1 year. All sites conducted monitoring for adverse events.	1.4% 1/72 • Number of events 1 • Adverse events were monitored throughout the study from the beginning of enrollment until both the 6-months post-manipulation under anesthesia and 1-year post-manipulation under anesthesia timepoints had been reached. Approximately 1 year. All sites conducted monitoring for adverse events.

Additional Information

Gabriel Schouten - Clinical Research Coordinator

Mayo Clinic

Phone: 5072665895

Email: schouten.gabriel@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place