Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty
Phase: NA
Conditions: Thumb Osteoarthritis
Sponsor: University of Toledo

1 
 
 
 
 
 
 
 
 
Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty 
 
NCT050307510 
Document date: document created for submission to UToledo IRB. Approval 
date of IRB 2/21/22. 
 
 

2 
 
THE ELEMENTS OF A RESEARCH PROTOCOL 
 
Influence of custom orthosis post CMC arthroplasty 
 
1. Background, Review of the Literature, Significance  
 
Carpometacarpal (CMC) osteoarthritis (OA) can cause severe pain and loss of hand function, 
thumb motion and thumb strength (Fontana et al., 2007). CMC arthroplasty, surgery on the 
thumb joint, is conducted when conservative treatments for CMC OA fail (Grenier et al. 
2016). In 2011, 6,960 CMC arthroplasties were conducted in the United States (Werner et al., 
2015). Splints or orthoses are typically used after surgery to immobilize the joint as the 
wound heals. Previous studies have reported mixed results in the comparison of outcomes 
related to use of custom orthoses and prefabricated splints (Baradaran et al., 2018; Sillem et 
al., 2011; Marotta et al., 2020; Bani et al., 2013). This study aims to compare post-surgical 
outcomes, including wound dehiscence, pain, function, and satisfaction with device and care 
from individuals who receive either a custom orthosis or prefabricated splint after CMC 
arthroplasty. This study will allow for increased understanding about the pros and cons of 
prefabricated splints versus custom orthosis which can inform clinical decisions in order to 
decrease wound dehiscence, the pain associated with wound dehiscence, and enhance 
function post-surgery for individuals who have CMC arthroplasty.   
 
2. Objectives/Specific Aims  
• To determine the difference in the incidence of wound dehiscence after a CMC 
arthroplasty when using a custom orthosis as compared to a prefabricated 
splint. 
• To determine the difference in subject reported pain levels after a CMC 
arthroplasty between those who received a custom orthosis as compared to 
those who received a prefabricated splint. 
• To determine the difference in function as measured by the QuickDASH, active 
range of motion measurements of the thumb, and subtests within the applied 
dexterity section of the Arthritis Hand Function Test (AHFT) between those 
wearing a custom orthosis as compared to those wearing a prefabricated splint. 
• To determine the difference in subject satisfaction with device and services at 
the first and second post-operative appointment.  
 
3. Methods 
 
a) Study Design  
• Experimental, two groups with random assignment 
 
 
b) Method of treatment assignment  
Subjects will be randomly assigned using at the initial follow-up appointment following 
CMC arthroplasty. The surgeon may exclude the subject, following assessment, if the 
subject cannot be randomly assigned to an intervention group. Open-label blinding will be 
used since every member of the team will be able to perceive whether the subject has 

3 
 
received a custom orthosis or prefabricated splint. Random assignment to the two groups 
will be completed in SPSS.  
 
 
c) Inclusion/exclusion criteria  
Inclusion criteria for subjects include status post CMC arthroplasty (within 4-5 
weeks), 18 or older, able to read and understand English, capable of independently 
consenting to health care procedures. 
Subjects will be excluded from the study if the surgeon identifies risk factors that 
would preclude random assignment to the control or experimental group. Subjects will 
also be excluded if they request a prefabricated or custom orthosis. 
 
d) Justification of the number of subjects  
Anticipated number of subjects that will be requested for enrollment is 125 subjects. A 
sample size of at least 96 is required for a power of 60 with α = .05.  
 
e) Study setting  
University of Toledo Medical Center (UTMC) outpatient. 
 
f) Primary and secondary outcome measures  
Primary Outcomes include: 
Function - as measured by the QuickDASH 
Wound dehiscence – as measured by the Sandy Grading System  
Pain - as measured by the Visual Analog Pain Scale 
Thumb CMC Active Range of Motion (AROM) measurements  
Subtests within the applied dexterity section of the Arthritis Hand Function Test 
Satisfaction with device and services – as measured by the OPUS. 
 
Secondary variables of interest include: 
Demographic data such as age, gender, race, handedness, pre-existing conditions 
current medications and supplements, smoking history, and alcohol consumption. 
 
h) Procedures, interventions, schedule  
 
FIRST POST-OP APPOINTMENT 
Standard of care: At the initial post-op appointment with the surgeon, the client will check in 
and register for the appointment. A member of the surgical team will assess the client and 
document the Sandy Score. 
Research specific: As a member of the surgical team assesses the client he/she will 
determine if the client meets the inclusion criteria. If the client does meet the inclusion criteria, 
the study will be briefly explained using the recruitment flyer. The client will then be asked if 
he/she is interested in participating. 
If the client is interested in participating, a member of research team will meet with the client 
to review the consent form and answer any questions. Once any questions have been 
answered, if the subject agrees to participate, he/she will sign the informed consent form. The 
subjects will be informed both verbally and in writing that they can take consent away at any 

4 
 
time during the research study. A copy of the informed consent form will be given to the 
subject. The client will be randomly assigned to intervention A or intervention B.  
Standard of Care: The subject will receive either a prefabricated splint (Intervention A) or 
custom orthosis (Intervention B). 
Research specific: The subject will then be asked to complete the demographic 
questionnaire, QuickDASH, and the Pain VAS. Thumb CMC active range of motion 
measurements will then be collected (radial and palmar abduction). Participants will also 
complete subtests within the applied dexterity section of the Arthritis Hand Function Test and 
OPUS survey. 
 
Subjects who are assigned to Intervention A (the prefabricated splint group) will be provided 
a splint by a member of the surgical team. Subjects who are assigned to Invention B (the 
custom orthosis group) will be evaluated by an occupational therapist and a custom orthosis 
will be fabricated. 
SECOND POST-OP APPOINTMENT 
Standard of Care: Approximately 4-5 weeks later, subjects will attend a second post-op 
appointment and be assessed by a member of the surgical team. The Sandy score will be 
documented.  
Research specific: At this time, a member of the research team will ask the subject to 
complete the, QuickDASH, and the Pain VAS. Thumb CMC active range of motion 
measurements will then be collected (radial and palmar abduction). Participants will also 
complete subtests within the applied dexterity section of the Arthritis Hand Function Test and 
OPUS survey. 
 
 
i) Planned data analysis  
Means and standard deviations will be calculated for the demographic information such as 
age and alcohol consumption per week. In-group and between-group percentages will 
also be calculated for demographic information, such as gender, pre-existing diabetes, 
and smoking history. The means and standard deviations of scores received on the 
QuickDASH, Sandy Grading System, Pain VAS, and AROM will be calculated. In-group 
and between-group descriptive statistics will be calculated for scores on the OPUS and 
Applied Dexterity section of the Arthritis Hand Function test. Independent student t-tests 
will be conducted to compare the means between Interventions A and B. Dependent 
student t-tests will be conducted to compare the initial post-op assessment mean data to 
the second post-op assessment mean data within groups. P-values will be considered 
significant if they are less than or equal to 0.05. 
 
4. Reference List 
Aebischer, B., Elsig, S., & Taeymans, J. (2016). Effectiveness of physical and occupational 
therapy on pain, function and quality of life in patients 
with trapeziometacarpal osteoarthritis - A systematic review and meta-analysis. Hand 
therapy, 21(1), 5–15. https://doi.org/10.1177/1758998315614037   
Baca, M. E., Rozental, T. D., McFarlane, K., Hall, M. J., Ostergaard, P. J., & Harper, C. M. 
(2020). Trapeziometacarpal joint arthritis: is duration of symptoms a predictor of 

5 
 
surgical outcomes? The Journal of Hand Surgery, 45(12), 1184.e1-
1184.e7. https://doi.org/10.1016/j.jhsa.2020.05.026  
Bani, M. A., Arazpour, M., Kashani, R. V., Mousavi, M. E., & Hutchins, S. W. (2013). 
Comparison of custom-made and prefabricated neoprene splinting in patients with the 
first carpometacarpal joint osteoarthritis. Disability & Rehabilitation: Assistive 
Technology, 8(3), 232–237. https://doi.org/10.3109/17483107.2012.699992   
Bani, M. A., Arazpour, M., Kashani, R. V., Mousavi, M. E., Maleki, M., & Hutchins, S. W. 
(2013). The effect of custom-made splints in patients with the first carpometacarpal 
joint osteoarthritis. Prosthetics and Orthotics International, 37(2), 139–
144. https://doi.org/10.1177/0309364612454047   
Baradaran, A., Baradaran, A., Ebrahimzadeh, M. H., Kachooei, A. R., Rivlin, M., 
& Beredjiklian, P. (2018). Comparison of custom-made versus prefabricated thumb 
splinting for carpometacarpal arthrosis: A systematic review and meta-analysis. The 
Archives Of Bone And Joint Surgery, 6(6), 478–485.   
Barnard, A. R., Regan, M., Burke, F. D., Chung, K. C., & Wilgis, E. F. S. (2012). Wound 
healing with medications for rheumatoid arthritis in hand surgery. ISRN Rheumatology, 
2012, 251962. https://doi.org/10.5402/2012/251962.  
Becker, S. J., Bot, A. G., Curley, S. E., Jupiter, J. B., & Ring, D. (2013). A prospective 
randomized comparison of neoprene vs thermoplast hand-based thumb spica splinting 
for trapeziometacarpal arthrosis. Osteoarthritis and cartilage, 21(5), 668–
675. https://doi.org/10.1016/j.joca.2013.02.006   
Berggren, M., Joost-Davidsson, A., Lindstrand, J., Nylander, G., & Povlsen, B. (2001). 
Reduction in the need for operation after conservative treatment of osteoarthritis of the 
first carpometacarpal joint: A seven year prospective study. Scandinavian journal of 
plastic and reconstructive surgery and hand surgery, 35(4), 415–
417. https://doi.org/10.1080/028443101317149381   
Bertozzi, L., Valdes, K., Vanti, C., Negrini, S., Pillastrini, P., & Villafañe, J. H. (2015). 
Investigation of the effect of conservative interventions in thumb carpometacarpal 
osteoarthritis: Systematic review and meta-analysis. Disability and Rehabilitation, 
37(22), 2025–2043. https://doi.org/10.3109/09638288.2014.996299  
Boonstra, A. M., Schiphorst Preuper, H. R., Reneman, M. F., Posthumus, J. B., & Stewart, R. 
E. (2008). Reliability and validity of the visual analogue scale for disability in patients 
with chronic musculoskeletal pain. International journal of rehabilitation 
research. Internationale Zeitschrift fur Rehabilitationsforschung. 
Revue internationale de recherches de readaptation, 31(2), 165–
169. https://doi.org/10.1097/MRR.0b013e3282fc0f93   
Crosby, C. A., Reitz, J. L., Mester, E. A., & Grenier, M.-L. (2013). Rehabilitation following 
thumb CMC, radiocarpal, and DRUJ arthroplasty. Hand Clinics, 29(1), 123–
142. https://doi.org/10.1016/j.hcl.2012.08.025   
Day, C. S., Gelberman, R., Patel, A. A., Vogt, M. T., Ditsios, K., & Boyer, M. I. (2004). Basal 
joint osteoarthritis of the thumb: a prospective trial of steroid injection and 
splinting. The Journal of Hand Surgery, 29(2), 247–
251. https://doi.org/10.1016/j.jhsa.2003.12.002  
De Smet, L., Sioen, W., Spaepen, D., & van Ransbeeck, H. (2004). Treatment of basal joint 
arthritis of the thumb: Trapeziectomy with or without tendon interposition/ligament 
reconstruction. Hand Surgery, 9(1), 5–9. https://doi.org/10.1142/S0218810404001942   
Earp, B. E. (2008). Treatment of advanced CMC joint disease: Trapeziectomy and implant 
arthroplasty (silastic-metal-synthetic allograft). Hand Clinics, 24(3), 
277. https://doi.org/10.1016/j.hcl.2008.04.004   

6 
 
Field, J., Buchanan, D. (2007). To suspend or not to suspend: a randomised single blind trial of 
simple trapeziectomy versus trapeziectomy and flexor carpi radialis suspension. J Hand 
Surg Eur 32(4), 462-466. doi.10.1016/J.JHSB.2007.02.005  
Fontana, L., Neel, S., Claise, J.-M., Ughetto, S., & Catilina, P. (2007). Osteoarthritis of the 
thumb carpometacarpal joint in women and occupational risk factors: A case-control 
study. The Journal of Hand Surgery, 32(4), 459–
465. https://doi.org/10.1016/j.jhsa.2007.01.014  
Frye, S. K., & Geigle, P. R. (2020). A comparison of prefabricated and custom made resting 
hand splints for individuals with cervical spinal cord injury: A randomized controlled 
trial. Clinical rehabilitation, 269215520983486. Advance online 
publication. https://doi.org/10.1177/0269215520983486  
Grenier, M. L., Mendonca, R., & Dalley, P. (2016). The effectiveness of orthoses in the 
conservative management of thumb CMC joint osteoarthritis: An analysis of functional 
pinch strength. Journal of hand therapy: official journal of the American Society of 
Hand Therapists, 29(3), 307–313. https://doi.org/10.1016/j.jht.2016.02.004   
Gummesson, C., Ward, M. M., & Atroshi, I. (2006). The shortened disabilities of the arm, 
shoulder and hand questionnaire (QuickDASH): Validity and reliability based on 
responses within the full-length DASH. BMC musculoskeletal disorders, 7, 
44. https://doi.org/10.1186/1471-2474-7-44   
Halilaj, E., Moore, D. C., Laidlaw, D. H., Got, C. J., Weiss, A.-P. C., Ladd, A. L., & Crisco, J. 
J. (2014). The morphology of the thumb carpometacarpal joint does not differ between 
men and women, but changes with aging and early osteoarthritis. Journal of 
Biomechanics, 47(11), 2709–2714. https://doi.org/10.1016/j.jbiomech.2014.05.005   
Hamann, N., Heidemann, J., Heinrich, K., Wu, H., Bleuel, J., Gonska, C., & Brüggemann, G. 
P. (2014). Stabilization effectiveness and functionality of different thumb orthoses in 
female patients with first carpometacarpal joint osteoarthritis. Clinical biomechanics 
(Bristol, Avon), 29(10), 1170–1176. https://doi.org/10.1016/j.clinbiomech.2014.09.007  
Kooner, S. S., Sheehan, B., Kendal, J. K., & Johal, H. (2018). Development of a simple 
multidisciplinary arthroplasty wound-assessment instrument: the SMArt Wound Tool. 
Canadian Journal of Surgery. Journal Canadien de Chirurgie, 61(5), 326–
331. https://doi.org/10.1503/cjs.015017  
London, D. A., Stepan, J. G., Lalchandani, G. R., Okoroafor, U. C., Wildes, T. S., & Calfee, R. 
P. (2014). The impact of obesity on complications of elbow, forearm, and hand 
surgeries. The Journal of Hand Surgery, 39(8), 1578–
1584. https://doi.org/10.1016/j.jhsa.2014.05.007   
Marotta, N., Demeco, A., Marinaro, C., Moggio, L., Pino, I., Barletta, M., Petraroli, A., 
& Ammendolia, A. (2020). Comparative effectiveness of orthoses for thumb 
osteoarthritis: A systematic review and network meta-analysis. Archives of Physical 
Medicine and Rehabilitation. https://doi.org/10.1016/j.apmr.2020.06.012   
Matullo, K. S., Ilyas, A., & Thoder, J. J. (2007). CMC arthroplasty of the thumb: A 
review. Hand (New York, N.Y.), 2(4), 232–239. https://doi.org/10.1007/s11552-007-
9068-9   
McKee, P., & Rivard, A. (2004). Orthoses as enablers of occupation: client-centred splinting 
for better outcomes. Canadian Journal of Occupational Therapy, 71(5), 306–314.  
Ooishi, D., Izumi, M., Ueba, H., & Ikeuchi, M. (2019). Splinting for the carpometacarpal joint 
relieves experimental basal thumb pain and loss of pinch strength. European Journal of 
Pain (London, England), 23(7), 1351–1357. https://doi.org/10.1002/ejp.1404  
Poole, J. L., Walenta, M. H., Alonzo, V., Coe, A., & Moneim, M. (2011). A pilot 
study comparing of two therapy regimens following carpometacarpal joint 

7 
 
arthroplasty. Physical & Occupational Therapy in Geriatrics, 29(4), 327–
336. https://doi.org/10.3109/02703181.2011.613530   
Rannou, F., Dimet, J., Boutron, I., Baron, G., Fayad, F., Macé, Y., Beaudreuil, J., Richette, 
P., Ravaud, P., Revel, M., & Poiraudeau, S. (2009). Splint for base-of-
thumb osteoarthritis: A randomized trial. Annals of Internal Medicine, 150(10), 661–
669.  
Rhee, P. C., Paul, A., Carlsen, B., & Shin, A. Y. (2019). Outcomes of surgical management for 
thumb basilar arthritis in patients 55 years of age and younger. Hand (New York, 
N.Y.), 14(5), 641–645. https://doi.org/10.1177/1558944718769378   
Roberts, R. A., Jabaley, M. E., & Nick, T. G. (2001). Results 
following trapeziometacarpal arthroplasty of the thumb. Journal of Hand Therapy: 
Official Journal of the American Society of Hand Therapists, 14(3), 202–
207. https://doi.org/10.1016/s0894-1130(01)80054-5  
Rosen, R., Manna, B. (2020). Wound 
Dehiscence. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK551712/  
Sandy-Hodgetts, K., Carville, K., Santamaria, N., Parsons, R., & Leslie, G. D. (2019). The 
Perth Surgical Wound Dehiscence Risk Assessment Tool (PSWDRAT): Development 
and prospective validation in the clinical setting. Journal of Wound Care, 28(6), 332–
344. https://doi.org/10.12968/jowc.2019.28.6.332   
Sandy-Hodgetts, K., Ousey, K., Conway, B., Djohan, R., Nair, H. K. R., Serena, T. E., & Tariq, 
G. (2020). International best practice recommendations for the early identification and 
prevention of surgical wound complications. London, UK; Wounds 
International. https://iswcap.org/wp-
content/uploads/2020/03/ESS20_CD_ISWCAP_WINT_web.pdf  
Shah, K. N., Defroda, S. F., Wang, B., & Weiss, A.-P. C. (2019). Risk factors for 30-day 
complications after thumb CMC joint arthroplasty: An American College of Surgeons 
national surgery quality improvement program study. Hand, 14(3), 357–
363. https://doi.org/10.1177/1558944717744341   
Siegel, P., Jackson, D., & Baugh, C. (2020). Practice patterns following carpometacarpal 
(CMC) arthroplasty. Journal of hand therapy: official journal of the American Society 
of Hand Therapists, S0894-1130(20)30206-4. Advance online 
publication. https://doi.org/10.1016/j.jht.2020.10.016   
Sillem, H., Backman, C. L., Miller, W. C., & Li, L. C. (2011). Comparison of two 
carpometacarpal stabilizing splints for individuals with thumb osteoarthritis. Journal of 
hand therapy: Official journal of the American Society of Hand Therapists, 24(3), 216–
230. https://doi.org/10.1016/j.jht.2010.12.004   
Silva, P. G., De Carvalho Silva, F., Da Rocha Corrêa Fernandes, A., & Natour, J. (2020). 
Effectiveness of nighttime orthoses in controlling pain for women with hand 
osteoarthritis: A randomized controlled trial. American Journal of Occupational 
Therapy, 74(3), 7403205080p1. https://doi.org/10.5014/ajot.2020.033621   
Thomsen, N. O., Jensen, C. H., & Nygaard, H. (2000). Weilby-Burton arthroplasty of 
the trapeziometacarpal joint of the thumb. Scandinavian Journal of Plastic and 
Reconstructive Surgery and Hand Surgery, 34(3), 253–
256. https://doi.org/10.1080/02844310050159846   
Tsehaie, J., Wouters, R. M., Feitz, R., Slijper, H. P., Hovius, S. E. R., & Selles, R. W. (2019). 
Shorter vs longer immobilization after surgery for thumb carpometacarpal 
osteoarthritis: A propensity score-matched study. Archives of Physical Medicine and 
Rehabilitation, 100(11), 2022. https://doi.org/10.1016/j.apmr.2019.02.016   
Vermeulen, G. M., Brink, S. M., Sluiter, J., Elias, S. G., Hovius, S. E. R., & Moojen, T. M. 
(2009). Ligament reconstruction arthroplasty for primary thumb carpometacarpal 

8 
 
osteoarthritis (Weilby technique): Prospective cohort study. Journal of Hand Surgery, 
34(8), 1393–1401. https://doi.org/10.1016/j.jhsa.2009.06.019   
Weiss, S., Lastayo, P., Mills, A., & Bramlet, D. (2004). Splinting the degenerative basal joint: 
Custom-made or prefabricated neoprene? Journal of Hand Therapy, 17(4), 401–
406. https://doi.org/10.1197/j.jht.2004.07.002  
Werner, B. C., Bridgforth, A. B., Gwathmey, F. W., & Dacus, A. R. (2015). Trends in thumb 
carpometacarpal interposition arthroplasty in the United States, 2005-2011. American 
Journal of Orthopedics (Belle Mead, N.J.), 44(8), 363–368.   
Witherow, E. J., & Peiris, C. L. (2015). Custom-made finger orthoses have fewer 
skin complications than prefabricated finger orthoses in the management 
of mallet injury: A systematic review and meta-analysis. Archives of physical medicine 
and rehabilitation, 96(10), 1913–1923.e1. https://doi.org/10.1016/j.apmr.2015.04.026  
Wollstein, R., Michael, D., & Harel, H. (2015). Postoperative therapy for chronic thumb 
carpometacarpal (CMC) joint dislocation. American Journal of Occupational Therapy, 
70(1), 7001350020p1. https://doi.org/10.5014/ajot.2016.017210  
Youngman, T., Del Core, M., Benage, T., Koehler, D., Sammer, D., & Golden, A. (2020). 
Patient-related risk factors associated with surgical site complications after elective 
hand surgery. Hand (New York, N.Y.), 
1558944720944260. https://doi.org/10.1177/1558944720944260