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MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty (MUA)

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ClinicalTrials.gov Identifier: NCT02739035
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : February 8, 2021
Sponsor:
Collaborator:
Knee Society
Information provided by (Responsible Party):
Matthew P. Abdel, M.D., Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Stiffness Following Total Knee Arthroplasty Drug: Dexamethasone Drug: Celecoxib Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
Actual Study Start Date : April 2016
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Drug: Dexamethasone
8 mg of IV dexamethasone immediately before MUA.
Other Name: Decadron

Drug: Celecoxib
2 weeks per mouth of celecoxib (200 mg daily)
Other Name: Celebrex




Primary Outcome Measures :
  1. Knee range of motion after manipulation [ Time Frame: 6 weeks after manipulation ]
    Knee range of motion measures will include both passive and active flexion and extension

  2. Knee range of motion after Total Knee Arthroplasty [ Time Frame: 1 year from the date of the Total Knee Arthroplasty ]
    Knee range of motion measures will include both passive and active flexion and extension


Secondary Outcome Measures :
  1. Knee Society Scores [ Time Frame: Baseline, 6 weeks after the MUA, and 1 year after the TKA ]
  2. 12-item Short Form Survey (SF-12) [ Time Frame: Baseline, 6 weeks after the MUA, and 1 year after the TKA ]
  3. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 6 weeks after the MUA, and 1 year after the TKA ]
  4. Promise-29 outcome form [ Time Frame: Baseline, 6 weeks after the MUA, and 1 year after the TKA ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739035


Contacts
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Contact: Lauren Cole (507) 284-5445 cole.lauren@mayo.edu

Locations
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United States, Arkansas
HipKnee Arkansas Foundation Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Becky Wilson       bwilson@hipkneearkansas.com   
United States, Colorado
Colorado Joint Replacement Recruiting
Denver, Colorado, United States, 80210
Contact: Aviva Pollet       AvivaPollet@centura.org   
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Anne DeBenedetti       Anne.DeBenedetti@rushortho.com   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lauren Cole    507-284-5445    ORCU@mayo.edu   
Principal Investigator: Matthew Abdel, M.D.         
United States, Nebraska
Univ. of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Peter Danielson       peter.danielson@unmc.edu   
United States, New York
Hospital for Joint Diseases Recruiting
New York, New York, United States, 10003
Contact: Daniel Waren       Daniel.Waren@nyumc.org   
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Kathleen Tam       tamk@HSS.EDU   
New York - Presbyterian at Columbia University Recruiting
New York, New York, United States, 10032
Contact: Walkania Santos       ws2590@cumc.columbia.edu   
United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Alexis Ready       Alexis.Ready@orthocarolina.com   
Duke University Medical Ceter, Dept. of Orthopaedics Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Friend       jennifer.friend@duke.edu   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alison Klika       klikaa@ccf.org   
Joint Implant Surgeons Recruiting
New Albany, Ohio, United States, 43054
Contact: Michael Sneller       snellerma@joint-surgeons.com   
United States, Pennsylvania
Rothman Institute Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact: Mason Buccilla       Mason.Buccilla@rothmanortho.com   
Aria 3B Orthopaedic Specialists Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Michelle Anderson       michelleanderson@ariahealth.org   
United States, Texas
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Thomas Sullivan       tsullivan@houstonmethodist.org   
United States, Utah
University of Utah Orthopaedic Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Shanna Lougmiller       Shanna.Loughmiller@hsc.utah.edu   
Sponsors and Collaborators
Mayo Clinic
Knee Society
Investigators
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Principal Investigator: Abdel Matthew, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Matthew P. Abdel, M.D., Consultant - Knee Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02739035    
Other Study ID Numbers: 15-009075
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dexamethasone
Celecoxib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action