MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
MUA
Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
1 other identifier
interventional
130
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2016
Longer than P75 for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedResults Posted
Study results publicly available
November 21, 2023
CompletedNovember 21, 2023
November 1, 2023
6.7 years
March 31, 2016
September 28, 2023
November 2, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
6 weeks after manipulation
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.
1 year from the date of the manipulation
Secondary Outcomes (17)
Knee Society Functional Score
6 weeks after the MUA, and 1 year after the MUA
Knee Society Knee Score
6 weeks after the MUA, and 1 year after the MUA
Short Form Survey 12-item Version 2 (SF-12v2): Physical Health
6 weeks after the MUA, and 1 year after the MUA
Short Form Survey 12-item Version 2 (SF-12v2): Mental Health
6 weeks after MUA, 1 Year after MUA
Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score
6 weeks after the MUA, and 1 year after the MUA
- +12 more secondary outcomes
Study Arms (2)
MUA alone
NO INTERVENTIONSubjects 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
EXPERIMENTALFor 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.
Interventions
8 mg of IV dexamethasone immediately before MUA.
2 weeks per mouth of celecoxib (200 mg daily)
Eligibility Criteria
You may qualify if:
- Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.
- MUA's scheduled between 6-10 weeks postoperatively
You may not qualify if:
- Intolerance to NSAIDs
- Renal dysfunction
- Age \< 18 or \> 90 years
- Primary diagnosis of rheumatoid arthritis
- Patients with a Glomerular Filtration Rate (GFR) \<60 as the cut off for Chronic Kidney Disease (CKD) (stage 3 CKD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Knee Societycollaborator
Study Sites (16)
HipKnee Arkansas Foundation
Little Rock, Arkansas, 72205, United States
Colorado Joint Replacement
Denver, Colorado, 80210, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Univ. of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hospital for Joint Diseases
New York, New York, 10003, United States
Hospital for Special Surgery
New York, New York, 10021, United States
New York - Presbyterian at Columbia University
New York, New York, 10032, United States
OrthoCarolina
Charlotte, North Carolina, 28207, United States
Duke University Medical Ceter, Dept. of Orthopaedics
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Joint Implant Surgeons
New Albany, Ohio, 43054, United States
Rothman Institute
Lansdale, Pennsylvania, 19446, United States
Aria 3B Orthopaedic Specialists
Philadelphia, Pennsylvania, 19106, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Participant dropout rates were higher than anticipated for in the initial enrollment calculations, and patient reported outcome surveys had low completion rates. As a result, the target of 90 power for results was not achieved for all study outcome metrics. Additional study is warranted regarding NSAID administration strategy for MUA patients in order to determine if NSAIDs can be useful in combatting the inflammatory cascade which is associated with arthrofibrosis and post TKA stiffness.
Results Point of Contact
- Title
- Gabriel Schouten - Clinical Research Coordinator
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Abdel Matthew, M.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant - Knee Surgery
Study Record Dates
First Submitted
March 31, 2016
First Posted
April 14, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
November 21, 2023
Results First Posted
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share