Conditions: Stiffness Following Total Knee Arthroplasty
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Dexamethasone intervention 2: Celecoxib
Intervention descriptions: intervention 1: 8 mg of IV dexamethasone immediately before MUA. intervention 2: 2 weeks per mouth of celecoxib (200 mg daily)

Protocol document:
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Manipulation Under Anesthesia (MUA) to Treat Postoperative 
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Stiffness after Total Knee Arthroplasty: 
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A Multicenter Randomized Clinical Trial 
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Matthew P. Abdel, M.D.  
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Paul Sousa, M.D., M.B.A.  
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Mark W. Pagnano, M.D. 
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Daniel J. Berry, M.D.  
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Principal Site:  Mayo Clinic, Rochester, Minnesota 
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INTRODUCTION 
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Stiffness after total knee arthroplasty (TKA) occurs when patients have difficulty flexing and 
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extending their knee for routine activities of daily living. Patients require 67 degrees of knee 
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flexion during the swing phase of gait, 83 degrees to ascend stairs, 90 degrees to descend stairs 
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and 93 degrees to rise from a standard chair.1 When less than 90 degrees of motion is reached 
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after TKA, the quality of life for patients is substantially decreased since simple activities like 
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walking can become difficult.2 3 
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Despite advancements in surgical technique, implant design and pain management, arthrofibrosis 
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(i.e., malignant stiffness) remains one of the top five reasons for revision TKA. At the upcoming 
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2016 American Academy of Orthopaedic Surgeons annual meeting, Matthew P. Abdel, M.D., 
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and colleagues will present their data indicating a contemporary arthrofibrosis rate of 5.8 percent 
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after primary TKA at Mayo Clinic. In addition, 2.8 percent of patients require a manipulation 
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under anesthesia (MUA). While there are alternatives to MUA, physical therapy shows only 
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modest gains and surgery is reserved for patients that fail non-operative management. With 
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MUA, mean flexion improved 35 degrees.  However, 5 percent of patients failed to maintain at 
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least 90 degrees of flexion after the MUA at our institution. More concerning, these results were 
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similar to the previous decade, where the rate of arthrofibrosis was 5.4 percent, with 2.9 percent 
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requiring MUA. The only identifiable risk factor for MUA was previous knee operation.  Lastly, 
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a manipulation under anesthesia significantly increased the risk for revision.  As one can see, the 
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incidence of arthrofibrosis following primary TKA has remained unchanged over the past two 
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decades. With the exponential increase in primary TKAs, arthrofibrosis is a large burden to the 
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patient, surgeon and entire U.S. health care system ($8.75 billion annually). 
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Preliminary clinical and translational research has indicated that an inflammatory disorder of the 
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musculoskeletal system may be responsible for post-operative stiffness in some patients.4-8 
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Although evidence remains limited to animal models, the inflammatory cascade plays a central 
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role in the formation, and recurrence, of arthrofibrosis, particularly at the time of insult (i.e. time 
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of index arthroplasty and/or MUA).7,9,10 This is essential as some insurance companies have 
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stopped covering this procedure. The purpose of this study was to determine the efficacy of 
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manipulation under anesthesia (MUA), with and without perioperative oral celecoxib and 
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intravenous (IV) corticosteroid. 
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PATIENTS AND METHODS 
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Study Design 
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This study is a prospective, multicenter, randomized clinical trial (RCT) designed to evaluate the 
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use of anti-inflammatory medications for the management of arthrofibrosis following primary 
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TKA. Patients will be randomly assigned to either the control or experimental group. Both groups 
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will receive a manipulation under anesthesia (MUA) if flexion is < 90 degrees at 4 –12 weeks 
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postoperatively.  Manipulation under anesthesia is the international standard of care for early 
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arthrofibrosis.  The control group will not receive any IV corticosteroids or PO non-steroidal anti-
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inflammatory medications (NSAIDs).  The experimental group will receive a single dose of IV 
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corticosteroids (8 mg IV dexamethasone immediately prior to MUA) and 2 weeks of PO celecoxib 
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at a dose of 200 mg daily.  Many surgeons, including several at the Mayo Clinic, consider the use 
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of IV corticosteroids and PO celecoxib the standard of care with a MUA.   
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Patients 
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Patients will be recruited from sixteen high-volume, academic, tertiary-care referral centers 
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(Table 1).  All enrolling centers have been vetted, as only surgeons that are members of the 
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prestigious closed Knee Society (representing the top 100 knee surgeons in the world) are 
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participating.  Patients approached for enrollment will have received a primary unilateral TKA 
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for a diagnosis of osteoarthritis. All primary TKA constructs will have constraint that is less than 
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that of varus-valgus constraint (VVC).  All VVC and hinged TKAs will be excluded.  Only 
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MUAs scheduled between 4 –12weeks postoperatively will be included.   
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Institutional Review Board (IRB) approval will be obtained from all respective institutions prior 
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to initiation of the study.  The Mayo Clinic will serve as the coordinating site. Patients will be 
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excluded from the study if any of the following exist:  (1) intolerance to NSAIDs, (2) renal 
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dysfunction, (3) age < 18 or > 90 years,  (4) primary diagnosis of rheumatoid arthritis and (5) 
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patients with GFR <60 as the cut off for CKD (stage 3 CKD).  Use of non-steroidal anti-
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inflammatory medications during the first two weeks after manipulation under anesthesia will 
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exclude patients from participation in this study. However, celecoxib (a non-steroidal anti-
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inflamatory medication) will be provided for those patients randomized to the experimental 
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group, once daily for fourteen days following the manipulation under anesthesia. Aspirin, used 
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routinely for DVT prophylaxis post-operatively, did not restrict patients from participation in this 
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study. Patients who are on NSAIDs prior to MUA, is ok to enroll. Patient demographics were 
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noted, including age at index arthroplasty, sex, body mass index (BMI), ASA score, and 
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Charlson Index. 
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Randomization 
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Patients will be randomized into one of 2 groups: (1) MUA only (i.e. control group) or (2) MUA 
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plus 8 mg of IV dexamethasone immediately before MUA, followed by 2 weeks of PO celecoxib 
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(200 mg daily) (experimental group). Assignment of patients into either group will be made prior 
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to the initiation of enrollment for the study. Patients will be randomized using a computer 
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generated (SAS PROC) block randomization schedule to ensure equivalent numbers of patients 
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in each group over the course of the study in case early stopping is required. The randomization 
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schedule will be generated by the Mayo Clinic Department of Epidemiology and Biostatistics 
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with the randomization list provided to the investigators prior to initiation of patient recruitment. 
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Neither the patient nor the treating physician were blinded the randomization group.   
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Manipulation Under Anesthesia 
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Patients will undergo MUA per their institutional protocol.  As previously noted, these will be 
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completed between 4 and 10 weeks postoperatively for flexion < 90 degrees.  Patients will 
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receive sedation per their institutional protocol.  Physical therapy (either supervised or 
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unsupervised) will be prescribed 2 -3 times per week for 4 – 6 weeks thereafter.   
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Outcome Measures 
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The primary outcome measure will be knee range of motion, including both passive and active 
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flexion and extension 6 weeks after the manipulation and 1 year from the date of the TKA. 
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Secondary outcomes will include comparison of Knee Society Scores (KSS), 12-item Short 
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Form Survey (SF-12v2), Knee Injury and Osteoarthritis Outcome Score (KOOS), and the 
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Promise-29 outcome form (Appendices 1-4). Outcomes will be documented pre-MUA, 6 weeks 
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after the MUA, and 1 year after the TKA. A standardize evaluation form will be shared amongst 
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all participating sites, and will be used consistently for all patients (Appendix 1-4). 
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Power Analysis 
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The mean and standard deviation for sample size calculation were derived from a study by 
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Yercan et al. In that study, the authors found that the mean ROM following MUA was 114° ± 
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16°.11  We hypothesized that a 10° difference in total range of motion would constitute a 
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clinically significant difference. With a type I error rate of 5%, 108 total patients (54 per arm) are 
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required to have 90% power to detect this difference. Accounting for a dropout rate of 20%, 65 
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patients per arm (130 total patients) will be recruited. 
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Statistical Analysis 
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All data will be summarized and reported descriptively using appropriate summary statistics, 
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including mean and standard deviation (SD) for continuous variables, and count and percentage 
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for categorical variables.  The analysis was focused on the two primary study outcomes: range of 
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motion (total arc of motion as well as angle of terminal knee flexion, measured in degrees), and 
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subjective outcome (KSS, SF-12v2, KOOS, and PROMIS).  Outcomes were compared between 
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the two study groups using two-sample t-tests if the data are approximately normally distributed; 
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if the data are not sufficiently normally distributed, non-parametric Wilcoxon rank sum tests was 
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used.  Since the subjects were assigned to the study groups in a randomized manner, no 
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significant differences between the subjects in the two groups were expected.  However, 
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apparent differences in subject demographics or baseline clinical data were evaluated, and 
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further analysis was undertaken using multivariable modeling to compare the two groups while 
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adjusting for other important variables.  When necessary and appropriate, the analysis was 
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adjusted for enrolling center.  Categorical outcomes were analyzed using chi-square tests and 
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logistic regression.  Separate analyses were performed for the 6-week and 1-year outcomes. All 
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statistical tests were two-sided and p-values less than 0.05 will be considered significant. 
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Sources of Funding 
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This study is partially supported by the Knee Society Branded Multi-Center Randomized Clinical 
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Trial Grant. 
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TABLES 
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Table 1. List of participating institutions included  
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Aria 3B Orthopaedic Specialists 
 
Colorado Joint Replacement  
 
Duke University Medical Center 
 
HipKnee Arkansas Foundation 
 
Hospital for Joint Diseases 
 
Hospital for Special Surgery 
 
Houston Methodist 
 
Joint Implant Surgeons 
 
Mayo Clinic 
 
New York-Presbyterian at Columbia University 
 
OrthoCarolina 
 
Rothman Institute 
 
Rush University Medical Center 
 
 
 
Cleveland Clinic 
 
University of Nebraska Medical Center 
 
University of Utah Orthopaedic Center 
 
 
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Table 2. Baseline demographics and clinical characteristics  
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Demographic and Clinical 
Characteristics 
MUA 
(N = X) 
MUA + AI 
(N = X) 
Demographic Characteristics 
     Age (year) 
     Sex (female/male) (no. of patients) 
     Weight (kg) 
     Height (cm) 
     BMI (kg/m2) 
     ASA Status (no. of patients) 
 
 
Implant Type 
 
 
Range of Motion 
     Total 
     Flexion Contracture 
     Extension Deficit 
 
 
 
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Table 3. Outcome following manipulation under anesthesia for stiffness after total knee 
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arthroplasty  
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Blood Loss, Drain Output, and Rate of 
Blood Transfusions 
MUA 
(N = X) 
MUA + AI 
(N = X) 
p value 
Six Week ROM 
     Total Pre-Manipulation 
     Flexion 
     Total 6 weeks Post-MUA 
     Flexion 
     < 90 degrees 
     < 80 degrees 
    Total 6 weeks Post-MUA 
     Flexion 
     < 90 degrees 
     < 80 degrees 
 
 
 
Six Week Subjective Outcome 
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     SF-12v2 
     KOOS  
     Promis 29 
 
 
 


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Blood Loss, Drain Output, and Rate of 
Blood Transfusions 
MUA 
(N = X) 
MUA + AI 
(N = X) 
p value 
One Year ROM 
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     Flexion 
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     Flexion 
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     < 80 degrees 
    Total 6 weeks Post-MUA 
     Flexion 
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     < 80 degrees 
 
 
 
One Year Subjective Outcome 
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     KOOS  
     Promis 29 
 
 
 
 
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REFERENCES 
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1. 
Laubenthal KN, Smidt GL, Kettelkamp DB. A quantitative analysis of knee motion 
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during activities of daily living. Phys Ther. Jan 1972;52(1):34-43. 
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2. 
Williams DP, O'Brien S, Doran E, et al. Early postoperative predictors of satisfaction 
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following total knee arthroplasty. Knee. Dec 2013;20(6):442-446. 
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3. 
Fitzsimmons SE, Vazquez EA, Bronson MJ. How to treat the stiff total knee 
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arthroplasty?: a systematic review. Clin Orthop Relat Res. Apr 2010;468(4):1096-1106. 
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4. 
Abdel MP, Morrey ME, Barlow JD, et al. Myofibroblast cells are preferentially expressed 
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early in a rabbit model of joint contracture. J Orthop Res. May 2012;30(5):713-719. 
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5. 
Abdel MP, Morrey ME, Grill DE, et al. Effects of joint contracture on the contralateral 
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unoperated limb in a rabbit knee contracture model: a biomechanical and genetic study. J 
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Orthop Res. Oct 2012;30(10):1581-1585. 
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6. 
Barlow JD, Hartzler RU, Abdel MP, et al. Surgical capsular release reduces flexion 
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contracture in a rabbit model of arthrofibrosis. J Orthop Res. Oct 2013;31(10):1529-
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1532. 
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7. 
Barlow JD, Morrey ME, Hartzler RU, et al. Effectiveness of rosiglitazone in reducing 
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flexion contracture in a rabbit model of arthrofibrosis with surgical capsular release: A 
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biomechanical, histological, and genetic analysis. Bone Joint Res. Jan 2016;5(1):11-17. 
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8. 
Nesterenko S, Morrey ME, Abdel MP, et al. New rabbit knee model of posttraumatic 
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joint contracture: indirect capsular damage induces a severe contracture. J Orthop Res. 
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Aug 2009;27(8):1028-1032. 
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9. 
Chevalier X, Goupille P, Beaulieu AD, et al. Intraarticular injection of anakinra in 
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osteoarthritis of the knee: a multicenter, randomized, double-blind, placebo-controlled 
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study. Arthritis Rheum. Mar 15 2009;61(3):344-352. 
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10. 
Emami MJ, Jaberi FM, Azarpira N, Vosoughi AR, Tanideh N. Prevention of 
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arthrofibrosis by monoclonal antibody against vascular endothelial growth factor: a novel 
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use of bevacizumab in rabbits. Orthop Traumatol Surg Res. Nov 2012;98(7):759-764. 
288 
11. 
Yercan HS, Sugun TS, Bussiere C, Ait Si Selmi T, Davies A, Neyret P. Stiffness after 
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total knee arthroplasty: prevalence, management and outcomes. Knee. Mar 
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2006;13(2):111-117. 
291 
 
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ICF_001.pdf: 
  
 
 
 
 
 
 
 
 
 
 
 
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February 4, 2022 
Not to be used after: February 3, 2023  
 
IRB#: 15-009075 00              E-sign 
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IRB Doc. Ctrl # 10013.26 
 
 
 
 
 
 
 
Name and Clinic Number 
 
 
RESEARCH PARTICIPANT CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
 
Study Title: Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness after 
Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial 
 
IRB#: 15-009075 
 
Principal Investigator: Dr. Matthew Abdel and Colleagues 
 
Please read this information carefully. It tells you important things about this research study. A 
member of our research team will talk to you about taking part in this research study.  If you 
have questions at any time, please ask us. 
 
Take your time to decide.  Feel free to discuss the study with your family, friends, and healthcare 
provider before you make your decision.   
 
To help you decide if you want to take part in this study, you should know: 
• Taking part in this study is completely voluntary.  
• You can choose not to participate.  
• You are free to change your mind at any time if you choose to participate.   
• Your decision won’t cause any penalties or loss of benefits to which you’re otherwise 
entitled. 
• Your decision won’t change the access to medical care you get at Mayo Clinic now or in 
the future if you choose not to participate or discontinue your participation.   
 
For purposes of this form, Mayo Clinic refers to Mayo Clinic in Arizona, Florida and Rochester, 
Minnesota; Mayo Clinic Health System; and all owned and affiliated clinics, hospitals, and 
entities. 
 
If you decide to take part in this research study, you will sign this consent form to show that you 
want to take part. We will give you a copy of this form to keep. A copy of this form will be put 
in your medical record. 
 
 
 


  
 
 
 
 
 
 
 
 
 
 
 
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Name and Clinic Number 
 
CONTACT INFORMATION 
 
 
You can contact … 
At … 
If you have questions about … 
Principal Investigator: 
Dr. Matthew Abdel 
 
Study Team Contact: 
Orthopedic Study 
Coordinator Staff 
 
 
Phone: 
(507) 284-2511 
 
Phone: 
(507) 538-3562 
 
Address: 
Mayo Clinic 
200 First Street SW 
Rochester, MN 55905 
 Study tests and procedures 
 Research-related injuries or 
emergencies 
 Any research-related concerns or 
complaints 
 Withdrawing from the research study 
 Materials you receive 
 Research-related appointments 
Mayo Clinic 
Institutional Review 
Board (IRB) 
Phone: 
(507) 266-4000 
Toll-Free: 
(866) 273-4681 
 Rights of a research participant 
 
Research Subject 
Advocate 
(The RSA is independent 
of the Study Team) 
Phone: 
(507) 266-9372 
 
Toll-Free: 
(866) 273-4681 
 
E-mail: 
researchsubjectadvocate@mayo.edu 
 
 Rights of a research participant 
 Any research-related concerns or 
complaints 
 Use of your Protected Health 
Information 
 Stopping your authorization to use 
your Protected Health Information 
Patient Account Services 
 
Toll-Free:  
(844) 217-9591 
 Billing or insurance related to this 
research study 
 
Other Information:   
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Website will not include information that can identify you. At most, the 
Website will include a summary of the results. You can search this Website at any time. 
 
 


  
 
 
 
 
 
 
 
 
 
 
 
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1. 
Why are you being asked to take part in this research study? 
 
 
You have exhibited a rare complication called postoperative stiffness that affects less than 5% of 
patients following a knee replacement surgery. While this complication is known, the cause and 
optimal treatment for this condition remains unknown.  
 
 
2. 
Why is this research study being done? 
 
 
Postoperative stiffness has been poorly studied. The best treatment option for this condition at 
this time is manipulation under anesthesia (MUA). While many patients regain range of motion 
not all return to optimal outcome.  
 
It is thought that inflammation can contribute to postoperative stiffness. We would like to 
investigate if anti-inflammatory medications can limit scar formation, and improve knee function 
following MUA. 
 
 
3. 
Information you should know 
 
 
Who is Funding the Study? 
 
A Knee Society grant is funding a portion of this multi-center study. 
 
 
4. 
How long will you be in this research study? 
 
 
Your participation in this study will be for about 1 year following your MUA.   
 
 


  
 
 
 
 
 
 
 
 
 
 
 
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5. 
What will happen to you while you are in this research study? 
 
 
If you agree to be in the study, you will be randomly assigned (like a coin toss) to receive MUA 
alone or MUA with anti-inflammatory medications, celecoxib and dexamethasone. You and the 
Principal Investigator can’t choose your study group. You will have an equal chance of being 
assigned to either group.  
 
If you are assigned to the MUA with anti-inflammatory medication group, an intravenous (into 
your vein) dose of dexamethasone will be given to you at the time of MUA. If in this group, you 
will also receive celecoxib. Similar to Advil (ibuprofen), this medication is a Non-steroidal Anti-
inflammatory drug (NSAID) and decreases inflammation. It has fewer gastrointestinal side 
effects than typical NSAID’s. You will be given a prescription to take to the pharmacy of your 
choice. You 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.  
 
Whether you receive the anti-inflammatory medications or not, you will be followed throughout 
your routine follow up to assess your continued progress. 
 
You will fill out questionnaires about your knee and quality of life. You will do this at the time 
you consent and at your 6-week and 1-year follow up visits. We hope that you will answer all of 
the questions, but you can skip any questions you don’t want to answer. The questionnaires will 
take about 15-20 minutes to complete. 
 
 
6. 
What are the possible risks or discomforts from being in this research 
study? 
 
 
Risks associated with you participation in this study remain small.  
 
Both celecoxib and dexamethasone are FDA approved to treat conditions of inflammation. Many 
people using either of these medications do not have serious side effects. 
 
Side effects of an intravenous dexamethasone may include: nausea, vomiting, heartburn, 
headache, dizziness, trouble sleeping, appetite changes, increased sweating, acne, or 
pain/redness/swelling at the injection site. Additionally, this medication may make your blood 
sugar level rise, which can cause or worsen diabetes.  
 


  
 
 
 
 
 
 
 
 
 
 
 
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Celecoxib has potential side effects as well including: stomach upset or gas and rise in blood 
pressure. Some people have an allergy to NSAID’s, which could cause severe headache, 
unexplained weight gain, and swelling of the hands or feet. Rarely, NSAID medications can 
impair the function of your kidneys and liver. However, the dose and duration of treatment used 
in this study would make either of these side effects exceedingly rare.  
 
 
7. 
Are there reasons you might leave this research study early? 
 
 
You may decide to stop at any time. You should tell the Principal Investigator if you decide to 
stop, and you will be advised whether any additional tests may need to be done for your safety. If 
you leave this research study early, or are withdrawn from the study, no more information about 
you will be collected; however, information already collected about you in the study may 
continue to be used. 
 
 
8. 
What if you are injured from your participation in this research study? 
 
 
Where to get help: 
If you think you have suffered a research-related injury, you should promptly notify the Principal 
Investigator listed in the Contact Information at the beginning of this form. Mayo Clinic will 
offer care for research-related injuries, including first aid, emergency treatment and follow-up 
care as needed. 
 
Who will pay for the treatment of research related injuries: 
Care for such research-related injuries will be billed in the ordinary manner, to you or your 
insurance.  You will be responsible for all treatment costs not covered by your insurance, 
including deductibles, co-payments and coinsurance. 
 
 
9. 
What are the possible benefits from being in this research study? 
 
 
The proposed benefits of this study would be to improve the treatment options for future patients 
experiencing your condition. While your knee may or may not benefit from this study, future 
patients may gain from the data collected in this study.  


  
 
 
 
 
 
 
 
 
 
 
 
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Name and Clinic Number 
It is our hope that manipulation along with the use of anti-inflammatory medications will 
improve knee range of motion and knee function for patients experiencing postoperative 
stiffness. 
 
 
10. 
What alternative do you have if you choose not to participate in this 
research study? 
 
 
You do not have to be in this study to receive treatment for your condition. Your other choices 
may include: 
• MUA without anti-inflammatory medications 
• No MUA, but continued physical therapy 
 
Talk to your Principal Investigator or your doctor if you have any questions about any of these 
treatments or procedures. 
 
 
11. 
What tests or procedures will you need to pay for if you take part in this 
research study?  
 
 
You and/or your insurance will need to pay for all tests and procedures for this study as they are 
considered part of your clinical care.  
 
If you have billing or insurance questions call Patient Account Services at the telephone 
number provided in the Contact Information section of this form. 
 
 
12. 
Will you be paid for taking part in this research study? 
 
 
You will not be paid to take part in this research study. 
 
 


  
 
 
 
 
 
 
 
 
 
 
 
Approval Date:  
February 4, 2022 
Not to be used after: February 3, 2023  
 
IRB#: 15-009075 00              E-sign 
Page 7 of 9 
IRB Doc. Ctrl # 10013.26 
 
 
 
 
 
 
 
Name and Clinic Number 
 
 
13. 
How will your privacy and the confidentiality of your records be protected? 
 
 
Mayo Clinic is committed to protecting the confidentiality of information obtained about you in 
connection with this research study. Data will be stored in electronic files and/or a cabinet, with 
access to study personnel as authorized by the investigator. The investigator will review the data 
on a regular basis (at least annually) to verify the validity of the data. 
 
During this research, information about your health will be collected. Under Federal law called 
the Privacy Rule, health information is private. However, there are exceptions to this rule, and 
you should know who may be able to see, use and share your health information for research and 
why they may need to do so. Information about you and your health cannot be used in this 
research study without your written permission. If you sign this form, it will provide that 
permission.   
 
Health information may be collected about you from: 
• Past, present and future medical records. 
• Research procedures, including research office visits, tests, interviews and 
questionnaires. 
 
Why will this information be used and/or given to others? 
• To do the research. 
• To report the results. 
• To see if the research was done correctly. 
 
If the results of this study are made public, information that identifies you will not be used. 
 
Who may use or share your health information? 
• Mayo Clinic research staff involved in this study.  
 
With whom may your health information be shared?  
• The Mayo Clinic Institutional Review Board that oversees the research.  
• Other Mayo Clinic physicians involved in your clinical care.  
• Researchers involved in this study at other institutions. 
• Federal and State agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health and other United States 
agencies) or government agencies in other countries that oversee or review research. 


  
 
 
 
 
 
 
 
 
 
 
 
Approval Date:  
February 4, 2022 
Not to be used after: February 3, 2023  
 
IRB#: 15-009075 00              E-sign 
Page 8 of 9 
IRB Doc. Ctrl # 10013.26 
 
 
 
 
 
 
 
Name and Clinic Number 
• The sponsor(s) of this study and the people or groups it hires to help perform this 
research. 
• A group that oversees the data (study information) and safety of this research. 
 
In addition, individuals involved in study oversight and not employed by Mayo Clinic may be 
allowed to review your health information included in past, present, and future medical and/or 
research records. This review may be done on-site at Mayo Clinic or remotely (from an off-site 
location). These records contain information that directly identifies you. However, the 
individuals will not be allowed to record, print, or copy (using paper, digital, photographic or 
other methods), or remove your identifying information from Mayo Clinic. 
 
Is your health information protected after it has been shared with others? 
Mayo Clinic asks anyone who receives your health information from us to protect your privacy; 
however, once your information is shared outside Mayo Clinic, we cannot promise that it will 
remain private and it may no longer be protected by the Privacy Rule. 
 
Your Privacy Rights 
You do not have to sign this form, but if you do not, you cannot take part in this research study. 
If you cancel your permission to use or share your health information, your participation in this 
study will end and no more information about you will be collected; however, information 
already collected about you in the study may continue to be used. If you choose not to take part 
or if you withdraw from this study, it will not harm your relationship with your own doctors or 
with Mayo Clinic. You can cancel your permission to use or share your health information at any 
time by sending a letter to the address below: 
 
Mayo Clinic 
Office for Human Research Protection 
ATTN:  Notice of Revocation of Authorization 
200 1st Street SW 
Rochester, MN  55905 
 
Alternatively, you may cancel your permission by emailing the Mayo Clinic Research Subject 
Advocate at: researchsubjectadvocate@mayo.edu 
 
Please be sure to include in your letter or email: 
• The name of the Principal Investigator, 
• The study IRB number and /or study name, and 
• Your contact information. 
 


  
 
 
 
 
 
 
 
 
 
 
 
Approval Date:  
February 4, 2022 
Not to be used after: February 3, 2023  
 
IRB#: 15-009075 00              E-sign 
Page 9 of 9 
IRB Doc. Ctrl # 10013.26 
 
 
 
 
 
 
 
Name and Clinic Number 
Your permission lasts until the end of this study, unless you cancel it.  Because research is an 
ongoing process, we cannot give you an exact date when the study will end. 
 
 
ENROLLMENT AND PERMISSION SIGNATURES: 
 
 
Your signature documents your permission to take part in this research.  
 
 
 
  
 
 
 
          
 
 
    
        
Printed Name  
 
 
 
Date (mm/dd/yyyy) 
 
Time (hh:mm am/pm) 
 
 
 
_______________________________ 
Signature 
 
Person Obtaining Consent  
• I have explained the research study to the participant. 
• I have answered all questions about this research study to the best of my ability. 
 
 
 
  
 
 
 
        
 
 
 
    
         
Printed Name  
 
 
 
Date (mm/dd/yyyy) 
 
Time (hh:mm am/pm) 
 
 
_______________________________ 
Signature 
 
 
sigParticipant
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