A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation
Phase: NA
Conditions: Healthy
Sponsor: Mayo Clinic

Revision Date: 8.16.2019 
 
A Comparison Study of Three Standard Wrist Orthoses to Limit 
Forearm Rotation 
 
IRB 18-008562 
 
NCT04130425 
 
Date: 8/16/2019 
 
 
 
 
Authors: 
Stephanie Kannas OTD, OTR/L, CHT 
Sarah Cashman,  OTR/L 
Sara Gross, OTR/L 
Maggie Malecha, M.S., OTR/L 
Adam Orlando, MOT, OTR/L 
Sanjeev Kakar, MD 
 
 
Program: 
Department of Physical Medicine & Rehabilitation  
Department of Orthopedic Surgery 
 
Institutions: 
Mayo Clinic, Rochester 
 
Corresponding 
Author: 
Stephanie Kannas, OTD, OTR/L, CHT 
Department of Physical Medicine & Rehabilitation  
Mayo Clinic, Rochester 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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CONFIDENTIAL 
 
 
Table of Contents 
 
1 
INTRODUCTION/SIGNIFICANCE ....................................................................................................... 3 
2 
STUDY OBJECTIVES ......................................................................................................................... 4 
3 
PATIENTS AND METHODS ................................................................................................................ 4 
3.1 
STUDY DESIGN .............................................................................................................................. 4 
     3.1.1    GENERAL DESIGN ....................................................................................................................... 4 
     3.1.2    PRIMARY OUTCOME VARIABLE .................................................................................................... 4 
     3.1.3    SECONDARY OUTCOME VARIABLES ............................................................................................. 5 
     3.2 
SUBJECT SELECTION AND WITHDRAWAL ................................................................................... 6 
     3.2.1    INCLUSION CRITERIA ................................................................................................................... 6 
     3.2.2    EXCLUSION CRITERIA ................................................................................................................. 6 
     3.3      STUDY PROCEDURES .................................................................................................................. 6 
     3.4       STATISTICAL PLAN ..................................................................................................................... 16 
     3.4.1    SAMPLE SIZE DETERMINATION .................................................................................................. 16 
     3.4.2    STATISTICAL METHODS ............................................................................................................. 16 
4 
DATA HANDLING AND RECORD KEEPING ................................................................................... 17 
4.1 
CONFIDENTIALITY ......................................................................................................................... 17 
4.2 
RECORDS RETENTION .................................................................................................................. 17 
5 
REFERENCES ................................................................................................................................... 18 
6 
APPENDIX:  ....................................................................................................................................... 19 
 
A       BUDGET ................................................................................................................................... 19 
 
B       ORTHOTICS STUDIED ............................................................................................................ 20 
 
C      FDA EXEMPTION FOR ORTHOSES ....................................................................................... 22 
 

 
 
 
 
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1  Introduction/Significance 
Common upper extremity injuries often need to heal with no wrist and forearm range of 
motion. Forearm range of motion includes supination and pronation. Injuries that 
necessitate limiting forearm range of motion include fracture patterns involving the distal 
radioulnar joint (DRUJ), proximal radioulnar joint (PRUJ), triangular fibrocartilage 
complex (TFCC), both bone forearm fractures, ulnar shortening procedures, radial and 
ulnar osteotomies, DRUJ instability (Slaughter, Miles, Fleming & McPhail, 2010; 
LaStayo & Lee, 1996).  Long arm orthoses, sugar tong orthoses and muenster style 
orthoses can all limit forearm rotation.   
Past research has indicated common methods of immobilization to include the following: 
sugar tongs cast/orthosis, muenster cast/orthosis, long arm cast/orthosis/or short arm 
cast/orthosis, and an antirotation orthosis.  A long arm cast/orthosis is excellent at 
limiting forearm rotation, yet it does not allow any elbow flexion and extension (Kim, 
Kook & Kim, 2012). In the study by Kim, Kook, & Kim (2012) the authors found that the 
sugar tong orthotic was as effective and limiting forearm rotation as the long arm 
orthotic.  The sugar-tong can decrease forearm rotation to 30% of their normal values 
(Kim, Kook, & Kim 2012; Gil, DeFroda, & Hsu, 2016). A sugar tong limits rotation based 
on the circumferential fit, but can be difficult to don and doff.   
The modified antirotation orthosis allows for elbow and wrist flexion and extension, yet it 
mainly limits pronation through proprioceptive input around 30 degrees and does not 
prevent rotation (Monsterio & Brou, 2007; Slaughter, Miles, Fleming, & McPhail, 2010).  
This type of orthosis can be helpful in non-surgical approach to limiting forearm rotation 
(Monsterio & Brou, 2007).  
Lawton, Nicolls, and Charoglu (2007) compared a long arm cast thumb spica versus a 
muenster thumb spica cast.  Results concluded that the muenster thumb spica allowed 
six more degrees of forearm rotation than the long arm cast; however, the muenster 
group maintained a 52 degree arc of elbow motion. In a small study done by Trocchia 
and Hammert (2012) a long arm cast allowed an 11 degree arc of forearm rotation, and 
the muenster cast allowed a 35 degree arc of forearm rotation.  These results suggest if 
no forearm rotation is desired a cast or orthosis that immobilizes the elbow is required 
(Troccia & Hammert, 2012). Often though it is beneficial to allow elbow motion to 
prevent unnecessary elbow joint stiffness, and a muenster cast or orthosis is required.  
A muenster style orthosis is designed to limit forearm rotation at the distal radioulnar 
joint (DRUJ) yet allowing elbow flexion and extension after an injury that necessitates 
limiting forearm rotation (Slaughter, Miles, Fleming & McPhail, 2010).  Muenster 
orthoses can be radial based or ulnar based.  A radial based muenster is another 
options and can reduce the pressure off the olecranon, yet it is difficult for a therapist to 
fabricate. In the study by Slaughter, Miles, Fleming and McPhail (2010), a radial based 
muenster was fabricated. This orthosis was compared with a sugar tongs orthosis, anti-
DRUJ rotation orthosis, and a custom wrist orthosis.  The muenster and sugar tongs 

 
 
 
 
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orthoses were the best at limiting forearm rotation in 5 subjects.  The sugar tongs did 
the best at limiting pronation.  
An ulnar based muenster places the wrist in neutral and blocks the elbow from full 
extension.  In our literature search, research articles did not include an ulnar based 
muenster orthosis.   
In addition to which orthosis limits rotation the best, the researcher must address 
measurement techniques to maintain accurate recording. In our literature search, the 
goniometric measurement of pronation and supination was used to determine which 
orthosis or cast limited forearm motion the best.  Limiting factors include measuring 
motion with a hand held goniometers.  A research study by Kim, Kook, and Kim (2012) 
limited measurement error by creating a custom-made goniometer device that placed all 
subjects in the same position.  
Currently, there are no research studies that compare the amount of forearm rotation in 
a traditional thermoplastic orthoses to newer materials such as a Delta Cast orthosis, or 
prefabricated muenster orthoses such as the Hely and Weber MTC Fracture Brace.   
The purpose of this study is to assess which orthosis-a traditional thermoplastic ulnar 
based muenster, a delta cast style muenster and the Hely and Weber MTC Fracture 
Brace-allows for the least amount of supination and pronation in a healthy population in 
the dominant extremity.  
Study Objectives   
 
Primary Objective 
To assess which orthosis-a traditional thermoplastic ulnar based muenster, a delta cast 
style muenster and the Hely and Weber MTC Fracture Brace- allows for the least 
forearm rotation (Supination/Pronation) in a healthy population in the dominant 
extremity.  
 
Secondary Objective:    
To assess through a questionnaire barriers of wearing an orthosis that limits forearm 
rotation such as the comfort of the fit, the weight of the orthosis, the ease of 
donning/doffing, does the orthosis cause pain, and the aesthetics of the orthosis.   
2 Patients and Methods 
2.1 Study Design 
2.1.1 General Design 
 
(B) Experimental Design  
Definition:  In this study, the same subjects (30) will have 2 custom orthoses 
fabricated by 2 different methods, and application of a prefabricated muenster 

 
 
 
 
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orthosis fit by the investigators.  Within each orthosis, the subject will be measured 
for forearm rotation using the same measuring device with electronic read out.  
 
2.1.2 Primary Outcome Variable 
Supination and pronation will be the primary outcome measures.  An electronic 
goniometer device will be manufactured by PizzaCake.  This device will hold the 
dominant upper extremity with straps above the elbow with a trough for the 
forearm and a handle for the hand to be held in a grip position.  This will allow for 
rotation to occur only at the proximal radioulnar joint and the distal radioulnar 
device.  Using electronic measurement will reduce bias and measurement error 
from the therapist.  
 
Photo below is similar to what will be manufactured for the study:  
 
2.1.3 Secondary Outcome Variables 
The Orthotics and Prosthetics User’s Survey (OPUS) is a well validated, self-report 
questionnaire consisting of five modules.  Therapy will use 5 questions from the OPUS: 
Satisfaction with Device and Services Module.   These five questions are scored on a 5-point 
likert scale from Strongly Agree to Strongly Disagree with a 6th option of “don’t know”.    
 
The five questions include- 
 
1). My orthosis fits well.  
 
2). The weight of my orthosis is manageable. 
 
3). It is easy to put on my orthosis.  
 
4). My orthosis is pain free to wear.  
 
5). My orthosis looks good.  
 

 
 
 
 
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The remaining 16 questions were excluded as it did not pertain to healthy volunteers wearing the 
orthosis only during his/her research participation.  
2.2 Subject Selection and Withdrawal 
2.2.1 Inclusion Criteria 
      Subjects will be selected to participate in the study if they have had no prior wrist or                  
elbow injuries on the dominant side of his/her body, time of 90-120 minutes to 
complete the study in one sitting.  All participants will be between the ages of 18-
100, speak and read English and have the ability to follow directions.  
2.2.2 Exclusion Criteria 
Subjects will be excluded if they have had prior wrist or elbow injuries on the 
dominant side of his/her body.  Examples include distal radius injuries with 
intraarticular involvement, ulna fractures with intraarticular involvement, ulnar sided 
wrist pain, known TFCC injuries, Elbow fractures that limited the PRUJ in forearm 
rotation.  Subjects with known rheumatoid arthritis deformities of the wrist or any 
prior wrist surgeries are excluded.  
2.3 Study Procedures 
Subjects will be recruited from using an email sent to employees in the hand clinic, 
the PM&R fellowship, and PM&R residency, and Physical Therapy School for 
recruitment. Word of mouth will also be utilized to recruit subjects.  Subjects will be 
screened to see if they have met the inclusion criteria.   
 
Consent processes will be initiated if the subject has met the inclusion criteria.  
 
The data collection sheet will collect gender, age, and hand dominance, 
height/weight for body mass index and arm circumferential measurements at the 
wrist, 1” below the antecubital fossa and 3” above the antecubital fossa.  There will 
be a checklist on the data sheet to ensure participants are meeting inclusion criteria 
for the study.  
 
All orthoses will be fit or fabricated on the dominant hand.  
 
The subject will be fit with a prefabricated Hely & Weber MTC Fracture Brace.  
Directions for fitting are depicted below and retrieved from https://www.hely-
weber.com/images/stories/instructions/641-642_IFU.pdf 
 

 
 
 
 
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The subject will have a muenster orthosis fabricated out of thermoplastics and 
secured with Velcro.   Directions for fabricated are written below.  
 
1). Place desired width stockinet on the subjects arm from the metacarpal 
phalangeal joints to 4” above the elbow 
2). Pad the ulnar styloid with Reston 
3). Measure the length of material required from metacarpal phalangeal joint to 4” 
above the elbow 
4). Measure the 75% of the circumference of the arm at the metacarpal phalangeal 
joints, wrist, and elbow.  
5). Cut out orthoplast with measurements 
6). Use the 2” high stretch bandage and start at the metacarpal phalangeal joints 
mold the orthoplast to the arm using the high stretch bandage with the shoulder at 
90 degrees, elbow at 90 degrees, neutral forearm, wrist in 10-20 degrees extension, 
and neutral deviation.  
7). Draw cutting lines on the orthosis for these principles 
 
a). Full metacarpal phalangeal joint flexion of digits II-V 
 
b). Follow the line of the third metacarpal for trim placements volar and dorsal.  
 
c). At the elbow the lateral and medial epicondyle must be in the orthosis.  
 
d). On the posterior side and from the olecranon trim the orthosis 4.5 inches 
proximally  
 
8). Trim the orthosis at marked lines 
9). Try on orthosis make modification and draw lines to rivet straps 
 
a). strap at the first web space 1” wide, rivet volar side 
 
b). strap over the DRUJ 2” wide, rivet dorsal side 
 
c). strap at the proximal forearm  2” wide, rivet dorsal side  
10).  Moleskin the edges  
11).  Rivet straps in place.  On other side place heated Velcro tap.  
12). Place rest at the elbow.  
 

 
 
 
 
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The final orthosis will be a muenster orthosis fabricated out of Delta Cast and 
secured with Velcro.   Directions for fabricating are depicted below and retrieved 
from  
http://handtherapyhub.com/GoaIndia/docs/HandoutForNO.pdf 

 
 
 
 
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The traditional orthosis will be fabricated by Sara Gross.  The Delta Cast orthosis will 
be fabricated by Sarah Cashman.  Maggie Malecha will fit each patient with the 
prefabricated muenster orthosis. Adam Orlando will obtain goniometric 
measurements from all subjects. Stephanie Kannas, will ensure all orthoses are 
fabricated to the standards listed above in fitting and fabrication.  Stephanie Kannas 
is a certified hand therapist with 18 years of experience.  Sara Gross, Sarah 
Cashman, and Maggie Malecha have all passed the Mayo competency in fabricating 
muenster orthoses.  
 
Patients will be randomized into one of 5 groups. Randomization will be conducted 
using sealed envelopes prepared using a randomization schedule provided by the 
study statistician. The schedule will randomize in 5 blocks of 6 (123; 132; 213; 231; 
312, 321) to avoid over allocation of the subjects into one group.  
 
The Hely & Weber MTC Fracture Brace is 1 
The thermoplastic orthosis is 2 
The delta cast orthosis is 3 
 
In efforts to reduce subject fatigue and bias, goniometric measurements will be 
taken following each randomization sequence of orthotic fabrication.  Subjects will 
be placed in the goniometric measurement device, and the subject’s dominant arm 
will be covered to reduce bias. Each subject will have 3 trials of goniometry for 
pronation and supination. Terminal motion will be based upon the patient 
experiencing increased pressure or felt restriction from the orthosis. The odd number 
subjects will supinate/pronate, supinate/pronate, supinate/pronate.  The even 
number subjects will pronate/supinate, pronate/supinate pronate/supinate.  
 
At the completion of measuring all three orthoses, the subjects will fill out the 5 
question survey regarding each orthosis.  After completion of the survey, the subject 
will be thanked for their time and dismissed from the study.   
 
We have attempted to reduce bias through having each therapist perform fabrication 
or fitting of the same orthosis and having the measurement device be electronic 
versus a therapist using a standard goniometer. The subjects will be blinded to the 
recorded data while performing supination/pronation as well.  
2.3.1 Sample Size Estimation 
 
The sample size estimation came from Dirk Larsen.  
Based on previously published papers, it is assumed that the standard deviation of 
the pronation-supination range of motion will be approximately 10°. Assuming that 
similar variability will be observed in the proposed study, a sample of 24 subjects will 
be required to have 80% power to detect a difference of at least 6° between any two 
of the 3 orthoses with respect to pronation-supination range of motion. In order be 
conservative, and to protect against potential subject attrition due to being unable to 

 
 
 
 
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complete the testing under all experimental conditions, a total of 30 subjects will be 
recruited and enrolled in the study. 
2.3.2 Statistical Methods 
All data will be summarized and reported using appropriate summary statistics 
including means and standard deviations for continuous variables, and counts and 
percentages for categorical variables. Results will be reported with 95% confidence 
intervals where appropriate. The analysis will focus on comparing the mean 
pronation-supination range of motion between the 3 different orthoses.  This will be 
accomplished using repeated measures analysis of variance (ANOVA). If the overall 
ANOVA result is statistically significant, further analysis will be undertaken to 
perform pairwise comparisons between the 3 study groups using an appropriate 
multiple comparisons procedure (such as the Tukey-Kramer method) to control the 
overall type-I error rate.  All statistical tests will be two-sided and p-values less than 
0.05 will be considered significant. 
3 Data Handling and Record Keeping 
3.1 Confidentiality 
Subjects will be asked to fill out the screening questionnaire, but their name will 
not be recorded or gathered on the questionnaire.  On the questionnaire, we will 
ask for gender, age, and hand dominance.  The questionnaire will also house the 
data for the 3 separate trials of the orthotics.  
 
3.2 Record Retention 
The questionnaires filled out by Mayo Clinic patients will be maintained for five 
years at the completion of the study.  The records will be kept in a locked filling 
cabinet at Mayo Clinic.  The data will also be housed in a secure data form such 
as an Excel Spreadsheet or Red Cap data base.  
 
 
 
 
 
 
 

 
 
 
 
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4 References 
Armstrong, A.D., MacDermid, J.C., Chinchalkar, S., Stevens, R.S., & King, G. J. W. 
(1998). Reliability of range-of-motion measurements in the elbow and forearm. Journal 
of Shoulder and Elbow Surgery, 7, 573-580.  
 
Gil, J. A., DeFroda, S. F., Hsu, R. Y. (2016). Modified sugar tong orthosis to avoid skin 
breakdown at the posterior elbow. American Journal of Emergency Medicine, 34, 307-
337.  
 
Karagiannopoulos, C., Sitler, M., & Michlovitz, S. (2003). Reliabilty of 2 functional 
goniometric methods for measuring forearm pronation and supination active range of 
motion. The Journal of Orthopaedic and Sports Physical Therapy, 33, 523-531.  
 
Kim, J.K., Kook, S. H., & Kim, Y. K., (2012). Comparison of forearm rotation allowed by 
different types of upper extremity immobilization. The Journal of Bone and Joint 
Surgery, 94, 455-460.  
 
LaStayo, P.C. (2002). Ulnar wrist pain and impairment: A therapist’s algorithmic 
approach to the triangular fibrocartilage complex. In E.J. Mackin, A.D. Callahan, & T.M. 
Skirven (Eds.). Rehabilitation of the hand and upper extremity (5th ed).  1156-1170. St. 
Louis, MO: Mosby.  
 
Lawton, J.N., Nicholls, M. A., & Charoglu, C. P. (2007). Immobilization for scaphoid 
fracture: Forearm roration in long arm thumb spica versus muenster thumb spica casts. 
Orthopedics, 30, 612-614.  
 
Monasterio, M., & Brou, K. E. (2007). Modified anti-pronation DRUJ instability splint. 
Journal of Hand Therapy, 19, 351-354.  
 
Slaughter, A., Mile, L., Fleming, J., & McPhail, S. (2010). A comparative study of splint 
effectiveness in limiting forearm rotation. Journal of Hand Therapy, 23, 241-248.  
 
Trocchia, A., Elfar, J.C., & Hammert, W. C. (2012). Biomechanical measurements of 
forearm pronosupination with common methods of immobilization. Journal of Hand 
Surgery, 37, 989-994.   
 
 
 
 
 

 
 
 
 
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Appendix A (Budget)*** 
Price 
Quantity 
Total 
Delta cast costs 
Material (5 orthoses/box) 
47.56 
7 
332.92 
Edging (15 yds) 
12.19 
4 
48.76 
Cloth/foam 
45.59 
3 
136.77 
Neoprene straps (1/16x2in, 7 yds) 
54.95 
2 
109.9 
Stockinet (15 yds) 
20.37 
2 
40.74 
Thermoplast munster costs 
Material (4 orthoses per sheet) 
90 
7 
630 
Velcro (for delta too; 1 in, 25 yds; Rolyan 1 in non-adhesive 
hook) 
44.23 
1 
44.23 
Straps (Rolyan 2 in, 25 yds adhesive) 
48.93 
2 
97.86 
Stockinet (3 in, 25 yds) 
13.15 
1 
13.15 
Pre-fab costs 
Left wrist component (regular) 
20.33 
1 
20.33 
Left wrist component (long) 
26.85 
1 
26.85 
Measurement device  
PizzaCake (Goniometry measure device) 
1750 
1 
1750 
Statistical support (data management, analysis,  etc.) 
2660 
1 
2,660.00 
Grand total 
  
  
$6,001.51  
 
 
 
***This is a requirement through the hand fellowship.  
Stephanie Kannas, Sarah Cashman and Sara Gross time is 
free.     Due to Maggie Malecha and Adam Orlando now 
being staff therapists, we will need approximately 90 hours 
of time total to complete the data collection for the two of 
them.  
 
Of note, we have attempted to recruit funds through the 
Orthopedic department, but Dr. Sanj Kakar is not eligible at 
this time for further internal funding through orthopedics.  
 
 
 
 
 
 

 
 
 
 
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Appendix B 
 
Hely & Weber MTC Fracture Brace 
 
 
 
Delta Cast Muenster 
 
The Orthosis fabricated at Mayo 
will have 2-2” straps on the 
forearm, and one neoprene one that 
crisscrosses from the epicondyles 
to the contralateral forearm.  

 
 
 
 
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Thermoplastic Muenster Orthosis  
 
 
 
 
 

 
 
 
 
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Appendix C