Proof of Concept: Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
Conditions: Osteoarthritis of the Small Joints of the Hand
Sponsor: Optimus3D S.L.

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Protocol version: Version 5 
Date of protocol: 03 Oct 2018 
Code: BIOFERULA3D 
 
 
Title of the study: Feasibility study: clinical validation of 3D personalized orthopedic splints in 
patients with rhizarthrosis. 
 
 
Product under study: “Bioférula3D”, personalized 3D splint classified as a custom-made 
medical device. 
 
 
 
 
Study population: patients with a new diagnosis of osteoarthritis of the trapeziometacarpal 
joint (TMJ) (rhizarthrosis). 
 
 
Sposor: Optimus 3D, S.L. 
Albert Einstein St, 15 
Miñano, Araba 
SPAIN 
Phone 1. + 34 605 887 006. 
Phone 2. +34 649 460 914 
 
 
 
Study duration: 8 months                                           
 
Main researcher: IÑIGO CEARRA GUEZURAGA, MD, PhD 
 
 
 
 
 
 
 
 
 
 
 
 
This protocol contains confidential information owned by the Sponsor and the Basque Public 
Health System 
 
 

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MAIN RESEARCHER: IÑIGO CEARRA GUEZURAGA  
PROYECT: BIOFERULA3D 
LENGHT: 8 months 
 
TITLE:  
"Feasibility study: clinical validation of 3D personalized orthopedic splints in patients with rhizarthrosis " 
 
Main objetive:  
• 
Evaluate the reduction of pain in patients with regular orthoses compared to the orthosis designed 
using 3D technology (VAS pain scale) 
 
Secondary objetives:  
 
• 
Evaluate the functionality between both groups (DASH scale) 
• 
Evaluate patient satisfaction between both groups (6-item scale) 
• 
Subjectively and retrospectively evaluate the time of use between both devices 
• 
Evaluate the strength, using grip and pinch dynamometers 
 
Study subjects: Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint (TMJ). 
 
Variables: Pain, functional capacity (DASH), satisfaction, time of use, strength, age, gender, employment 
status, marital status and educational level. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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GENERAL INFORMATION 
 
1. STUDY IDENTIFICATION 
 
Title: Feasibility study: clinical validation of 3D personalized orthopedic splints in patients with 
rhizarthrosis  
 
Code: BIOFERULA3D  
 
Study design: Randomized prospective follow-up 
 
Product under study: “Bioférula3D”, personalized 3D splint classified as a custom-made medical 
device. 
 
Version and date: Version 5, 10/3/2018 
Approved by: CREC (Clinical Research Ethics Committee) from OSI Bilbao Basurto 
(10/17/2018) 
 
Identification of the promoter and coordinator 
 
Sponsor: Optimus 3D, S.L. 
 
Coordinator: INNOSASUN (BIOEF) 
 
1.1. Identification of the promoter representative 
Mr. Fernando Oharriz, D. Alberto Ruiz de Olano 
Albert Einstein St, 15 
Miñano, Araba 
Spain 
Email: foharriz@optimus3d.es 
           aruiz@optimus3d.es 
 
Phone 1. + 34 605 887 006 
Phone 2. +34 649 460 914 
 
1.2. Information of the main investigators from the participating centers 
Basurto University Hospital (OSI Bilbao Basurto). 
The list of researchers participating in the study is detailed in Annex I "Centers and Research 
Team". 
 
 
 

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Information on other services involved: 
 
BIOEF (Innosasun): Clinical study coordination 
 
OSI Bilbao Basurto Research Unit 
 
OSI Bilbao Basurto CREC (Clinical Research Ethics Committee)  
 
2. ABSTRACT 
 
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger 
joints and is a major cause of disability. This affectation constitutes one of the main causes of 
consultation for hand pain. The level of discomfort varies depending on the type of work and the 
idiosyncrasy of each patient and ranges from slight discomfort and limitations depending on the 
patient, to notable pain and impediments. In addition to the clinic, radiology is used in the diagnosis 
and control of evolution. The Eaton-Littler classification (Stages I-II-III-IV) is commonly used. 
Treatment of stages I, II, and in some cases stage III, is conservative and is based on 
pharmacological and rehabilitation measures, including the use of orthoses or splints. 
In an ideal situation, these devices should allow freedom of movement and functionality of the 
hand, being the basis for adequate completion of the treatment (adherence), which could lead to 
an improvement in pain and functional limitations. 
There are currently several types of splints on the market made of temperature-moldable plastic 
material, a splint that has multiple disadvantages in terms of manufacturing. 
Additive manufacturing, frequently associated with the concept of 3D printing, encompasses a set 
of technologies that is transforming the way of designing and manufacturing application products in 
many and very diverse sectors. The development of the 3D bio-splint is a project opportunity for a 
new 3D orthosis that will allow a qualitative leap in the search for an intelligent solution for patients 
with rhizarthrosis. 
Splints developed using this method have a number of advantages both in manufacturing and for 
patients. Therefore, we proposed a proof-of-concept (feasibility) study. The objectives of this study 
are exploratory and seek to assess the feasibility of applying a personalized splint compared to a 
conventional one. 
As such, the study tries to find out if the personalized splint can be suitable for the treatment of 
patients with osteoarthritis of the TMJ and obtain at least similar results, providing greater wearing 
comfort and facilitating an improvement in the development of the activities of the daily life to 
patients. Therefore, it is not a design aimed at evaluating the efficacy of such treatment. It is a 
prospective study with two arms, open with 1: 1 allocation. 

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The study will be carried out in the outpatient clinics of the OSI Bilbao-Basurto Orthopedic Surgery 
and Traumatology Service with the collaboration of the Rehabilitation Service. 
The study will include a recruitment visit and two follow-up visits, one at a month and another final 
visit at 3 months. Se incluirán pacientes con nuevo diagnóstico de artrosis de la articulación 
trapecio-metacarpiana. Patients with a new diagnosis of osteoarthritis of the trapezius-metacarpal 
joint will be included. One group of patients will wear the usual splint indicated by the Service 
physicians and the other group the personalized splint designed by the company OPTIMUS 3D. 
The main variable is pain, which will be measured, as is usual practice, by a visual analog scale 
(VAS). In addition, the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire will be 
used in its Spanish version (DASHe) and questions about patient satisfaction with the use of 
splints. 
 
3. JUSTIFICATION 
 
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger 
joints and is a major cause of disability (1). In relation to the hand, after the distal interphalangeal 
joints, the most affected joint is the trapezius metacarpal joint (TMJ) (2). 
Rhizarthrosis is defined as a degenerative alteration of the trapezius-metacarpal joint (TMJ) 
characterized by a progressive deterioration of the articular surfaces and neo bone formation in 
them 
Osteoarthritis of the TMJ is a disease present in a large part of the general population. The 
symptomatic prevalence is estimated at 6-8% of the population, although its radiological 
prevalence would be 29-76% depending on the series studied (3). Its diagnosis is basically clinical, 
although radiological tests are very useful to confirm it and to typify the evolution of the disease. 
This affectation constitutes one of the main causes of consultation for hand pain. Clinically, 
patients present pain and decreased functional capacity, which is essentially expressed as a 
limitation of the range of motion and loss of grip, which generates inability to perform basic 
activities of life (3). 
The TMJ has a great range of mobility, since it basically serves to oppose the thumb to the rest of 
the fingers and carry out grasping or pinching actions, which is why it is of great use and of great 
utility in everyday life. This range of movements is favored by being a not very congruent joint, but 
this fact also explains the tendency to instability, which can lead to abnormal movements between 
the joint surfaces, which ultimately lead to the development of osteoarthritis of the joint. Over time, 
a subluxation occurs and the first metacarpal tends to approach the rest of the fingers, producing 
an adduction. This osteoarthritis leads to pain and functional disability. The pain is usually greater 
when the joint is stressed, during pinching movements.  
 

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The level of discomfort varies depending on the type of work and the idiosyncrasy of each patient 
and ranges from slight discomfort and limitations depending on the patient, to notable pain and 
impediments. Besides, the degree of discomfort is usually variable over the years and one can 
speak of outbreaks of the disease in some cases. Work or professional activity also contributes on 
the degree of perception of discomfort. 
On examination, limitation of joint mobility is observed, so that the degree of excursion of the first 
metacarpal is limited. Mobility is usually painful. As times goes by, the evolution towards a 
deformation with a tendency to a progressive subluxation of the first metacarpal over the trapezius 
is observed. The base of the first metacarpal is displaced to a dorsal subluxation. The head of the 
metacarpal adducts and the first phalanx hyperextended. This subluxation component adds a 
worse prognostic factor that influences the choice of treatment. 
In addition to the clinic, radiology is used in the diagnosis and control of evolution. The Eaton-Littler 
classification (4) is commonly used, which proposes 4 stages: 
Stage I: normal joint or slight widening 
Stage II: Joint narrowing due to cartilaginous wear and osteophytes <2mm 
Stage III: Joint narrowing and osteophytes> 2mm 
Stage IV: Trapezioscaphoid involvement with great trapeziometacarpal narrowing 
This radiological classification has therapeutic implications. Although not strictly, in stages III and 
IV the treatment is fundamentally surgical, with a wide range of proposed techniques, including 
ligament reconstruction, osteotomy of the base of the first metacarpal, interposition arthroplasty, 
prosthesis or arthrodesis of the joint (5). 
On the other hand, the treatment of stages I, II and in some cases of stage III, is conservative and 
is based on pharmacological and rehabilitation measures, including functional education and joint 
hygiene, kinesitherapy, electrotherapy, intra-articular infiltrations and the use of orthoses or splints 
(6). 
However, the mainstay of conservative treatment would be orthotic devices, which have been 
shown to reduce pain (7). Although there are no clear data to confirm this, it can be assumed that 
a decrease in pain could be expected to increase functional capacity (8) In an ideal situation, these 
devices should allow freedom of movement and functionality of the hand, being the basis for 
adequate treatment completion (adherence), which could lead to an improvement in pain and 
functional limitations (2). 
Despite these facts, there are no guidelines that specify what type of orthosis is best suited for 
treatment (9). Studies carried out until recently have focused on clinical parameters, being 
necessary to incorporate other variables such as the perception of the patient, their comfort, which 
will lead to greater adherence to treatment and, therefore, to improve their pain and functionality. 
As mentioned, in the initial treatment for rhizarthrosis, among other measures, a thumb abduction 
splint is usually prescribed, which seeks to put the thumb in a more physiological position (in  
 

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abduction instead of adduction) in which the articular surfaces remain in better relationship, and 
also seeks to stabilize the joint and relieve it of mechanical demand during daily activities. 
The first axis of the hand (Trapezius (carpus) - first metacarpal - proximal and distal phalanges) 
tilts at the joint between the trapezius and the first metacarpal. It is a very loose joint, allowing a 
wide range of thumb motion. The most important movement for the functionality of the hand is that 
of opposition, that is, the one that allows the thumb to pivot until it is placed opposite the rest of the 
fingers, enabling the pincer function. 
When there is a rhizarthrosis or degeneration of the trapezius-metacarpal joint, the greatest pain 
occurs precisely with the pinching. Biomechanically, the force or pressure exerted with the tip of 
the finger is transmitted by the lever arm of the aforementioned column, multiplying the mechanical 
demand at the base of the same, in the trapezius-metacarpal joint. This force can subluxate the 
joint. Both pressure and subluxation are causes of pain. Therefore, the goal of any orthosis is to 
immobilize and support this joint. 
 
3.1 Conventional orthoses 
 
Currently there are several types of splints made of temperature-moldable plastic material, a splint 
that has multiple disadvantages in terms of manufacture: 
-Polypropylene shrinks with heat, so it must be taken into account when designing. In addition, 
special care must be taken when heating and thermoforming it since the orthosis can collapse 
more easily. If it does not heat up enough, it may not fit well. 
-Rectifications cannot be made, so extreme care shoud be taken with the mold, and it is mandatory 
to make screeds or modifications before adapting the polypropylene, since once it has been fused, 
no changes can be made. 
Another type of splints that exist on the market are splints made of polyethylene sheets adjustable 
with velcro. The disadvantage of these splints consists of their instability in immobilization: they do 
not hold firmly, since they do not fit perfectly to the affected area. 
Given that the moments in which the patient has more pain are those in which they are exerting 
efforts with their hands, there is an increasing tendency to make more ergonomic and smaller 
models, which even allow wearing gloves on the orthosis if the worker requires it, and plastic 
materials that can get wet. 
Additive manufacturing, frequently associated with the concept of 3D printing, encompasses a set 
of technologies that is transforming the way of designing and manufacturing application products in 
many and very diverse sectors. 3D printing is based on the creation of objects, from a 
computerized file, by superimposing layers of material. 3D printing or additive manufacturing is one 
of the main axes on which Advanced Manufacturing or Industry 4.0 is based, considered by the 
European Union as Key Enabling Technology (KET), and therefore, a priority line of action. 
 

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The great potential of this technology, as well as its versatility, has made it enter different markets, 
standing out that of Biosciences-Health. 3D printing allows the custom fabrication of anatomical 
models for surgical guides, surgical instruments, implants, prostheses, immobilization orthoses, 
etc. It can be printed on different plastic materials, resin, titanium, other metals, etc. The latest 
advances in health applications are based on the combination of biology, the creation of 
biomaterials and 3D printing, evolving to what is known as bioprinting. 
Additive manufacturing, within this trend, facilitates the creation of an orthosis fully adapted to the 
anatomy of each patient. With the design freedom provided by 3D computing tools, the product will 
be lightened and manufactured in materials that can be wetted. 
 
 
3.2 Advantages of the 3D orthosis 
 
The development of the 3D bio-splint is a project opportunity for a new 3D orthosis that will allow a 
qualitative leap in the search for an intelligent solution for patients with rhizarthrosis. 
The splints developed using this method have a series of advantages both in manufacturing and 
for patients, among which we can highlight: 
 
• Increase the precision in the design of the splint to place it in the affected area. 
• Reduce the weight of the splint in order to lead a more agile life. 
• Improve perspiration. 
• Resistance to water, which will improve hygiene, the patient can even bathe with the splint on. 
• Greater mobility. The “pincer” movement will not be affected. 
• Allow air circulation. 
• Improve aesthetic appearance: simple splint design that can be covered if the patient considers it 
so, for example, with gloves. 
• Manufacturing times: the 3D model is made in 3 hours and can be in use by the patient in 72 
hours. 
• It can be made with fully recyclable materials. 
 
Below is a comparative summary table of the advantages of the 3D orthoses compared to current 
“conventional” orthoses: 
 
 
 
 
 
 

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CONVENTIONAL ORTHOSES’                                       ADVANTAGES OF 3D ORTHOSES 
ASPECTS TO IMPROVE  
 
Standard orthosis sizes.  
Comfort of the affected 
patient. 
-Customized splint adapted to the anatomy 
of each patient. (Scan to obtain 3D model of 
affected anatomy and fully customized CAD 
design). 
Thermoplastic Materials / 
PP / Plastic Cloth (Nylon) 
Heavy orthosis. Causes 
excessive heat and 
sweating. 
-Lightened splint both with the material and 
its density (possibility to edit the internal 
density of the material). 
-The range of materials offered by additive 
manufacturing will allow testing different 
materials and considering the most 
appropriate in terms of their rigidity-flexibility. 
 
PP manufacturing process
Difficulty in manufacturing 
the PP (see section 3.1.) 
-Additional manufacturing is a simple 
process by which the structure of the orthosis 
can be manufactured without any problem by 
melting the plastic and creating the 3D layer 
by layer. This technique gives total freedom 
to the design, being able to create pieces 
unthinkable with other manufacturing 
methods. 
 
Manufacturing times 
                                   Fabrication of an orthosis can be finished in 3 
hours approximately.  
 
Usually closed orthosis 
design 
Causes excessive heat 
and sweating. 
-Orthosis design freedom: openings / holes 
... 
 
Complete immobilization 
of the hand 
The pitching is affected. 
The patient cannot 
perform daily activities 
 
-Immobilization of the trapezius-metacarpal 
joint but nearly not affecting pitching  
 
 
3.3 3D bio-splint design (3D orthosis) 
 
Immobilization is the initial treatment for rhizarthrosis, currently carried out using an orthosis or 
splint made of moldable plastic material or adjustable polyethylene sheets with velcro. These 
orthoses have a standard size of measurements (2-3 sizes) so they do not adapt to the anatomy of 
100% of the patients. In addition, they are splints that cause excessive heat, weight bearing and 
the impossibility of cleaning or bathing. Due to these reasons, patients tend to fail to follow the 
immobilization procedure prescribed by clinicians (7-10 hours a day with the splint on). 
Faced with this problem, the company OPTIMUS 3D has seen the need to develop a new 
procedure to treat limb immobilization or orthotic external aid, providing splints with greater comfort 
and possibly improvement in the completion of the treatment, in addition to a better usability of the 
splint for the patient. The basic idea of the project is to manufacture the splint adapting it exactly to 
the physical configuration of the affected hand of the specific patient. The personalized splint will 
adapt exactly to the dimensions of the affected hand, thereby improving adherence to treatment 
and minimizing the discomfort derived from the use of standardized splints in sizes. 

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In patients with rhizarthrosis, the greatest pain appears in the fine and maintained pinch 
movement. For this reason, the splint should fix the trapezometacarpal joint fully and the 
metacarpal phalangeal joint partially. The splint will free the movement of the interphalangeal joint 
thanks to which you can perform daily activities that do not involve much effort. 3D printing will 
allow a splint design fully adapted to the anatomy of each user. 
A scan will be carried out, in the orthopedist's own office, of the possible affected areas that will 
allow the modeling of anthropomorphic data collection to be carried out using software where a 
huge cloud of points obtained from the scan of each patient will be modeled. be able to obtain a 
fabricable 3D model, that is, a design of the bio-technical parameters of the splint, defining and 
taking into account when designing the custom 3D splint, all the medical and biological aspects 
necessary to avoid health problems and increase comfort. 
OPTIMUS 3D will carry out the engineering and development of the splints using 3D printing 
technologies.  
 
 
3.4 Product development: 3D custom splints 
 
- 
Detailed modeling of the data taken in the scan. Detailed and specific modeling of the data 
taken by the 3D scanner will be carried out. Using the scanner, a point cloud of the model is 
obtained, which will be output in .stl format. This .stl file will be exported to a modifiable vector 
format to be refined and obtain a 3D model of the affected anatomy with which it will be worked 
later in 3D CAD software. 
- 
Design using 3D software of the models necessary for the manufacture of the prototypes. 
The design will be made optimally based on the 3D model of the patient obtained in the scan. A 
design will be created that perfectly fits and wraps the 3D model of the member adjusting the 
immobilization zones as specified in the load book. Once the orthosis has been designed, it can be 
exported in STL (stereolithrography) format necessary for printing on 3D printing machines. This 
file is the one that is used as input or input file for 3D printers, it is the digital representation of the 
model to be printed, from its CAD version. In other words, the STL format (or, failing that, STP. Or 
IGES. Exportable to STL format) will be necessary to be able to print in 3D. These files can be 
obtained from various 3D CAD design software. What is needed is to make an export of the digital 
model that has been built and to worry about saving the file in the necessary format. 
 
 
4. HYPOTHESIS 
 
3D manufactured orthoses manufactured are effective tools in the conservative treatment of 
rhizarthrosis in terms of pain reduction. 
 

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5. OBJETIVES 
 
The objectives of this study are exploratory since it is a proof-of-concept or feasibility study, which 
seeks to assess the feasibility of applying a personalized splint compared to a conventional one. 
We estimate that the clinical results, pain and function of the custom splint will be at least as good 
as those of conventional splints, but providing greater comfort and satisfaction for the patient. 
 
Main objective 
- 
Evaluate the reduction of pain in patients with usual orthoses compared to the orthosis 
designed using 3D technology (VAS pain scale) 
 
Secondary objetives  
- 
Evaluate the functionality between both groups (DASH scale) 
- 
Assess patient satisfaction between both groups (6-item scale) 
- 
Subjectively and retrospectively evaluate the time of use between both devices 
- 
Evaluate the strength, using pinch and grip gauges (dynamometers) 
 
 
6. DESIGN OF THE STUDY 
 
This study is a proof of concept or feasibility study. As such, the study tries to find out if the 
personalized splint can be suitable for the treatment of patients with osteoarthritis of the TMJ and 
obtain at least similar results, providing greater comfort of use and facilitating an improvement in 
the development of life activities daily to patients. Therefore, it is not a design aimed at evaluating 
the efficacy of such treatment. 
Prospective study with two arms, open with 1: 1 allocation. 
The study will be carried out in the outpatient clinics of the OSI Bilbao-Basurto Orthopedic Surgery 
and Traumatology Service with the collaboration of the Rehabilitation Service. 
The study will include a recruitment visit and two follow-up visits, one after the first month and 
another final visit at the 3-month period 
 
7. SUBJECTS OF STUDY 
 
Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint (TMJ) will be 
included according to the “recruitment plan” established in Annex III. 
 
 
 

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Inclusion criteria 
- 
Age between 18 and 75 years 
- 
Clinical diagnosis of rhizarthrosis 
- 
Radiological stage of the classification of Eaton-Littler I/II 
- 
Patients in whom a orthosis or splint is clinically indicated 
- 
Score between 3 and 7 on the VAS pain scale (range 0 to 10) 
 
Exclusion criteria 
- 
Previos treatment of rhizarthrosis  
- 
Refueses to participate in the study 
- 
Disabilities that prevent the completion of the questionnaires 
- 
Severe deformations in the hand 
- 
Presence of other alterations, such as carpal tunnel syndrome, tendinitis, or chronic 
inflammatory arthropathies 
 
Interventions 
 
One group of patients will wear the usual splint indicated by the staff physicians and the other 
group the personalized splint designed by the company OPTIMUS 3D. 
Patients will be asked to wear the splint for as long as possible, not to disrupt their normal activities 
(work, household, or otherwise). 
 
Assignment to the treatment branch 
 
Participation in the study will be offered to patients on a consecutive basis. Those patients who 
meet all the inclusion criteria, none for exclusion and sign the Informed Consent, will be 
randomized to receive the personalized splint or the control branch (conventional splint). Because 
the sample size is small and in order to avoid relevant imbalances in the final number of 
participants in each branch, the sample allocation process will follow a system of randomization by 
blocks (n = 4) and stratified by the level of activity of the patient. This will also try to ensure 
comparability between the groups in terms of the variable "activity" 
 
Blinding 
 
It does not apply in the present study. It is designed as an open study, since it cannot be blind, 
neither for patients nor for physicians, due to the fact that one branch will carry splints adapted to 
each patient and must be prepared by scanning the hand in the consultation itself. 
 

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8. SAMPLE SIZE 
 
This study has not been designed to test specific statistical hypotheses, so there is no justification 
for the sample size, since the study is designed as a proof of concept. It is intended to include 20 
patients in each treatment arm. 
 
 
9. VARIABLES TO RECORD 
 
- 
- The main variable is the pain that will be measured, as is usual practice by a visual 
analog scale from 0 (no pain) to 10 (excruciating pain). 
 
Pain has been chosen as the main variable, under the hypothesis that as the splint is more 
comfortable it may be worn longer and this would imply a decrease in pain (Annex IV) 
 
 
- As a secondary variable, we will use the DASH questionnaire (10) to assess functional 
capacity. It is a self-administered questionnaire, which consists of a central body of 30 
items that measure function and symptoms. Besides, there are 2 optional modules, with 4 
items each, designed to measure the impact of an upper limb injury when playing musical 
instruments and when doing sports or working. Each item is scored from 1 to 5, with 
increasing values depending on the intensity of the symptoms. The score of the items in the 
central body is added to obtain a total score, which can range from 30 to 150 points and 
which is transformed into a scale from 0 (best possible score) to 100 (worst possible score). 
Optional modules, where applicable, are scored separately using the same method. The 
DASH makes it possible to assess the disability perceived by the patient to perform various 
activities, including activities of daily living and symptoms such as pain, stiffness or loss of 
strength. 
 
The choice of this variable is justified since it is the questionnaire usually used both clinically and in 
studies to assess functional capacity (Annex IV). 
 
- To assess patient satisfaction, a satisfaction scale composed of 6 items will be used, each 
one scored from 0 to 10, that is, a scale of 11 points (11) (Annex IV) 
 
The choice of this variable is justified by the personalized design, with which it is expected that the 
patients will be more satisfied in the items to be evaluated. 
 
 

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- The evaluation of the time of use, in hours / day, of the different splints will be done by 
direct question to the patient. 
 
This variable is considered as a surrogate variable, since using the splint for a longer time may 
possibly improve pain and functionality. 
 
- 
Finally, the grip and pinch strength will be evaluated before the splint and later, by means of 
a dynamometer in the consultation. 
 
 
Other variables that will be included will be: 
 
Age, gender, employment status (housekeeping, active, sick leave, retired), marital status (single, 
divorced, separated / married, as a couple), level of studies (no studies / primary, high school / se 
secondary or equivalent and higher) 
 
 
10. FOLLOW-UP AND DATA COLLECTION 
 
The data will be collected in three visits. The baseline visit, in which the inclusion / exclusion 
criteria are checked and the corresponding treatment is assigned. 
In the control branch, the doctors prescribe the usual splint for each patient. In the intervention 
branch the personalized splint. 
At the baseline visit, the patients will be clinically examined, an X-ray will be taken to verify the 
inclusion criteria, and the DASH, VAS for pain, and pressure force will be completed. 
On the second visit, one month after the splint, pain, satisfaction, DASH, wearing time and grip 
strength will be evaluated. 
At the third follow-up visit (end of the study) that will take place at the third month of follow-up 
(between 11-14 weeks), patients will complete the DASH questionnaire, the VAS pain scale (from 
0-no pain to 10-worse imaginable pain), the pressure force, the time of use and the satisfaction 
questionnaire made up of 6 items, on an 11-point scoring scale, in which satisfaction will be 
assessed. 
The data of the patients and of the study variables will be collected by the specialists of each of the 
centers involved in the study. These data will be collected in a data collection notebook and 
entered into a database designed and adapted for this study. 
At the end of the data collection, the errors they may contain will be eliminated by checking logical 
ranges and detecting impossible codes. Likewise, any errors found will be corrected by checking 
the clinical history. Once it is considered that the data are refined, they will be closed for statistical 
analysis. 

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11. STATISTIC ANALYSIS 
 
For the descriptive analysis of the quantitative variables, the mean and standard deviation, median 
and interquartile range will be used. For qualitative variables, frequencies and percentages will be 
used. 
The quantitative variables, pain level and DASH score will be compared, both at baseline and at 
follow-up, as well as the difference between both moments, as well as time and satisfaction, 
between the two groups of patients using the T-test of Student or non-parametric Mann-Whitney U 
test, depending on whether the variables follow a normal distribution or not. The comparison of 
qualitative variables between both groups, such as gender, marital status, educational level or type 
of work, expressed as percentages, will be carried out using the Chi-square test or Fisher's exact 
test. 
On the other hand, it will be analyzed within each group of patients if the change in pain and 
functionality (DASH scale) between baseline and follow-up has been significant or not using the 
paired t test or the non-parametric Wilcoxon test for data couplets. 
Finally, the general linear model will be used to compare the decrease in pain or the improvement 
in functionality between the two groups of patients, adjusting for pain or baseline functionality. 
Changes in pain or functionality are considered as the dependent variable of the model, and the 
group (main independent variable) and the baseline pain or functionality scores as independent. 
 
 
12. ETHICAL CONSIDERATIONS 
 
Prior to conducting the study, this protocol will be submitted to the evaluation of the CREC (Clinical 
Research Ethics Committee) from OSI Bilbao Basurto. The patients included in the study will not 
be subjected to any risk other than that which they must suffer from the usual medical care of their 
disease and that due to the disease itself. No patient will be included or any study procedure will 
be carried out until the informed consent in writing has been obtained after written and oral 
information (Annex II: Information to the patient and informed consent). 
The information procedure will consist of the following phases: 
a) In the presence of the patient, the Information Sheet and Informed Consent will be 
read aloud in a clear and concise manner 
b) All doubts that may arise will be clarified 
c) Sufficient time will be allowed for patient to sign the Informed Consent 
Participation in the study will not entail any extra expense on the part of the patient. The study will 
not begin in any center until the Managing Director of the same has given his express authorization 
to it. 
 

Page 16 of 30 
 
 
13. DESCRIPTION OF THE TECHNIQUE TO BE USED IN THE STUDY 
 
The project will be carried out in the outpatient clinics of the OSI Bilbao-Basurto Orthopedic 
Surgery and Traumatology Service with the collaboration of the OSI Rehabilitation Service. 
This study will include a recruitment visit and two follow-up visits, one at first month and another 
final visit at 3 months. 
Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint will be included. One 
group of patients will wear the usual splint indicated by the staff physicians and the other group, 
the personalized splint designed by the company OPTIMUS 3D. 
The main variable is pain, which will be measured, as is usual practice, by a visual analog scale 
(VAS). In addition, the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire will be 
used in its Spanish version (DASHe) and questions about patient satisfaction with the use of 
splints. 
In the first recruitment visit, following the criteria and specifications of the "Recruitment Plan in 
relation to patient participation" (Annex III), Optimus 3D will scan the patient with rhizarthrosis to 
obtain the necessary information with which the model will be created.  
The patient, seated, will keep the arm extended on a table, leaving the area of the wrist and hand 
in the air without support. The wrist will be kept in a functional position, simulating holding a glass. 
When the clinician verifies the correct position of the affected limb, the scan will begin. 
The Optimus 3D technician will rotate the 3D scanner of the ASORCAD equipment around the 
patient's arm for approximately 1 minute. The scanner connected to a laptop will collect the 
anatomical data generating a point cloud that will be exported as a mesh (.stl format). This model 
will be used to begin the custom splint design process. 
 
 
14. LIMITATIONS OF THE STUDY 
 
The limitations of the study include the following:  
- 
- The Eaton-Litter classification is subject to intra-observer and inter-observer variability. 
This fact can affect the classification of patients. However, it is the most used in the 
literature. 
- 
The standard splint does not consist of a single model, but there are several available to 
patients. This fact means that the control group can contain different models. However, this 
is what happens in routine clinical practice. 
- 
Being a proof of concept study, the comparisons are exploratory.  
 
 
 

Page 17 of 30 
 
 
15. DURATION AND FOLLOW-UP OF THE STUDY 
 
Prior to the beginning of the study, a representative of the promoter or coordinating center will 
contact the principal investigator and the services involved in the study at each center to review the 
Protocol together with the data collection notebook (DCN). The objective is to clarify any doubts 
that may arise prior to the start of the study. 
During the course of the study, follow-up visits will be made periodically by a coordinator to check 
the progress of the study, control the documentation generated, help gather the required data and 
answer any questions that may arise. 
The objective of this procedure is to verify that all documentation and files are up-to-date and 
guarantee compliance with all protocol requirements and applicable local and national regulations, 
as well as the competent authorities. 
The phases in this study will be: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tasks 
Months 
1-2 
3 
4-6 
6-7 
7-8 
8 
1.-  Documentation: Protocol and DCN 
 
 
 
 
 
 
 
2.- AEMPS and CREC
 
 
 
 
 
 
 
3.- Recruitment and follow-up of patients
 
 
 
 
 
 
4.- Debugging of the database
 
 
 
 
 
 
 
5.- Data analysis
 
 
 
 
 
 
 
6.- Results presentation
 
 
 
 
 
 
 

Page 18 of 30 
 
 
16. REFERENCES 
 
 
 (1)  Cooper, C., Egger, P., Coggon, D., Hart, D. J., Masud, T., Cicuttini, F., Doyle, D. V., Spector, T. D., 
Generalized osteoarthritis in women: pattern of joint involvement and approaches to definition for 
epidemiological studies, J. Rheumatol., 23, 1938, 1996. 
 (2)  Gomes Carreira, A. C., Jones, A., Natour, J., Assessment of the effectiveness of a functional splint for 
osteoarthritis of the trapeziometacarpal joint on the dominant hand: a randomized controlled study, J. 
Rehabil. Med., 42, 469, 2010. 
 (3)  Hirschfeld, M., Galan, A., Arenas, J., Del, A. B., Benitez-Parejo, N., Costa, J. A., Guerado, E., [Inter-
observer agreement on the Eaton-Littler classification of trapeziometacarpal joint osteoarthritis], Rev. 
Esp. Cir. Ortop. Traumatol., 58, 237, 2014. 
 (4)  Eaton, R. G., Littler, J. W., Ligament reconstruction for the painful thumb carpometacarpal joint, J. 
Bone Joint Surg. Am., 55, 1655, 1973. 
 (5)  Garcia-Paredero E, Cecilia-Lopez D, Suarez-Arias L, Resines-Erasun C, Resultados del tratamiento 
quirúrgico de la rizartrosis mediante artrodesis trapeciometacarpiana con placa de osteosíntesis 
cuadrangular, Rev. Esp. Cir. Ortop. Traumatol., 54, 203, 2010. 
 (6)  Spaans, A. J., van Minnen, L. P., Kon, M., Schuurman, A. H., Schreuders, A. R., Vermeulen, G. M., 
Conservative treatment of thumb base osteoarthritis: a systematic review, J. Hand Surg. Am., 40, 16, 
2015. 
 (7)  Barron, O. A., Glickel, S. Z., Eaton, R. G., Basal joint arthritis of the thumb, J. Am. Acad. Orthop. 
Surg., 8, 314, 2000. 
 (8)  Bani, M. A., Arazpour, M., Kashani, R. V., Mousavi, M. E., Maleki, M., Hutchins, S. W., The effect of 
custom-made splints in patients with the first carpometacarpal joint osteoarthritis, Prosthet. Orthot. Int., 
37, 139, 2013. 
 (9)  Hamann, N., Heidemann, J., Heinrich, K., Wu, H., Bleuel, J., Gonska, C., Bruggemann, G. P., 
Stabilization effectiveness and functionality of different thumb orthoses in female patients with first 
carpometacarpal joint osteoarthritis, Clin. Biomech. (Bristol. , Avon. ), 29, 1170, 2014. 
 (10)  Hervas, M. T., Navarro Collado, M. J., Peiro, S., Rodrigo Perez, J. L., Lopez, M. P., Martinez, T., I, 
[Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and 
responsiveness], Med. Clin. (Barc. ), 127, 441, 2006. 
 (11)  Becker, S. J., Bot, A. G., Curley, S. E., Jupiter, J. B., Ring, D., A prospective randomized comparison 
of neoprene vs thermoplast hand-based thumb spica splinting for trapeziometacarpal arthrosis, 
Osteoarthritis. Cartilage., 21, 668, 2013. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 19 of 30 
 
 
ANNEXES 
 
Annex I:   
Participating Centers and Research Team 
 
CENTER
SERVICE
COLLABORATING RESEARCHER
Basurto University Hospital 
(OSI Bilbao Basurto) 
Orthopedic Surgery  
Iñigo Cearra Guezuraga MD, PhD 
Félix Manuel Silió Ochandiano MD, PhD 
Borja Cuevas Martínez, MD 
Rehabilitation 
Mª Lourdes Vadillo Jáuregui, MD 
Research Unit 
Antonio Escobar Martínez MD, PhD 
Iñigo Gorostiza Hormaetxe MD, PhD 
Amaia Bilbao MD, PhD 
Optimus 3D, S.L. 
I+D+i 
Mr Fernando Oharriz 
Mr Alberto Ruiz de Olano 
Mrs Izaskun Arriaga 
 
 

 
 
Page 23 of 30 
 
Annex III:  
 
Recruitment plan related to patient participation  
 
 
1. All members of the Orthopedic Surgery and Rehabilitation services will be informed, in the 
morning session, that initially ALL patients with a first diagnosis of rhizarthrosis in the outpatient 
clinic must be referred to the Hospital's Outpatient Traumatology Consultations, with 
symptomatic treatment and with recommendation of relative rest and analgesics. The clinics 
included are: Dr Areilza, Rekalde, Deusto, Txurdinaga, Santutxu, Javier Sáenz de Buruaga, 
Begoña and Bombero Etxaniz. 
 
2. To facilitate the appointment, patients will be referred with PREFERENCE and directed to 
ORTHOPEDIC SURGERY - RHIZARTHROSIS CLINIC. When doing it in this way, the specific 
day of the consultation is not given by the administrator of each outpatient clinic, but the request 
documents are sent by fax to the Hospital's Outpatient Clinics, where the administrators are 
aware of the study and the days available for citation. In the outpatient clinic, then, the patient 
receives the information that the appointment will be notified by mail or telephone, and it will 
take place within a maximum period of 15 days. 
 
3. The administrative staff of the Hospital's Outpatient Clinics will have, each month, at least two 
consultation spaces for the study of rhizarthrosis, so that no patient waits more than 15 days. 
These days will be determined with one month in advance, depending on the availability of the 
doctors, the consultation spaces, and the needs of the service. These inquiries will be notified, 
also within one month, to the company Optimus 3D. It is not expected to have more than 5 
patients each day. The Orthopedic Surgeons who will attend these consultations are doctors 
Iñigo Cearra and Borja Cuevas. It is estimated to need about 20 minutes per patient. 
 
4. In the office, it will be determined, from among all the patients, which ones meet all the inclusion 
criteria and none of the study exclusion criteria. The randomization will be carried out by the 
Hospital Research Unit. The patients in the experimental group will be scanned the same day of 
consultation by Optimus 3D company, with the objective of delivering the orthosis as soon as 
possible, estimating the time from scanning to delivery in 5 working days. Patients who are 
unable or unwilling to enter the study will be treated according to normal practice. 
 
5.  Follow-up consultations will be carried out at one month and at three months, after this first 
consultation, to evaluate the result of the treatment. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Page 24 of 30 
 
Annex IV:   
Variables in data collection notebook (DCN). 
 
 
PAIN VAS 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No 
pain 
 
 
 
 
 
 
 
 
 
Maximum 
pain 
 
 
DASH QUESTIONNAIRE 
 
 

 
 
Page 25 of 30 
 
 
 
 
 
 
 
 
 
 

 
 
Page 26 of 30 
 
 
 
 
 
 
 
 
 
 

 
 
Page 27 of 30 
 
 
 
PATIENT SATISFACTION 
 
 
1. 
What is your level of satisfaction with the splint? 
 
2. 
Has the splint helped decrease your pain? 
 
3. 
Has the splint helped you maintain your daily activities? 
 
4. 
Has it improved your quality of life? 
 
5. 
How comfortable was the use of the splint? 
 
6. 
How easy has it been to follow the instructions for using the splint? 
 
 
Answers are on a scale from 0 to 10 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Not 
satisfied at 
all 
 
 
 
 
 
 
 
 
 
Very 
satisfied 
Has not 
helped me 
at all 
 
 
 
 
 
 
 
 
 
Has helped 
me a lot 
Has not 
helped me 
at all 
 
 
 
 
 
 
 
 
 
Has helped 
me a lot 
Has not 
improved 
at all 
 
 
 
 
 
 
 
 
 
Has 
improved 
a lot 
Not 
confortable 
at all 
 
 
 
 
 
 
 
 
 
Very 
confortable
Not easy 
at all 
 
 
 
 
 
 
 
 
 
Very easy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Page 28 of 30 
 
 
Annex V: Declaración of Helsinki 
 
World Medical Association Declaration of Helsinki 
Ethical Principles for Medical Research Involving Human Subjects 
 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964; amended by the 29th 
WMA General Assembly, Tokyo, 
Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA 
General Assembly, Hong Kong, 
September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, 
October 1996, and the 52nd WMA 
General Assembly, Edinburgh, Scotland, October 2000 
 
A. Introduction 
1. The World Medical Association has developed the Declaration of Helsinki as a statement of 
ethical principles to provide guidance to physicians and other participants in medical research 
involving human subjects. Medical research involving human subjects includes research on 
identifiable human material or identifiable data. 
2. It is the duty of the physician to promote and safeguard the health of the people. The physician’s 
knowledge and conscience are dedicated to the fulfillment of this duty. 
3. The Declaration of Geneva of the World Medical Association binds the physician with the words, 
‘‘The health of my patient will be my first consideration,’’ and the International Code of Medical 
Ethics declares that, ‘‘A physician shall act only in the patient’s interest when providing medical 
care which might have the effect of weakening the physical and mental condition of the patient.’’ 
4. Medical progress is based on research which ultimately must rest in part on experimentation 
involving human subjects. 
5. In medical research on human subjects, considerations related to the well-being of the human 
subject should take precedence over the interests of science and society. 
6. The primary purpose of medical research involving human subjects is to improve prophylactic, 
diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of 
disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must 
continuously be challenged through research for their effectiveness, efficiency, accessibility and 
quality. 
7. In current medical practice and in medical research, most prophylactic, diagnostic and 
therapeutic procedures involve risks and burdens. 
8. Medical research is subject to ethical standards that promote respect for all human beings and 
protect their health and rights. Some research populations are vulnerable and need special 
protection. The particular needs of the economically and medically disadvantaged must be 
recognized. Special attention is also required for those who cannot give or refuse consent for 
themselves, for those who may be subject to giving consent under duress, for those who will not 
benefit personally from the research and for those for whom the research is combined with care. 
9. Research Investigators should be aware of the ethical, legal and regulatory requirements for 
research on human subjects in their own countries as well as applicable international 
requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or 
eliminate any of the protections for human subjects set forth in this Declaration. 
 
B. Basic principles for all medical research 
10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity 
of the human subject. 
11. Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant sources of 
information, and on adequate laboratory and, where appropriate, animal experimentation. 
12. Appropriate caution must be exercised in the conduct of research which may affect the 
environment, and the welfare of animals used for research must be respected. 

 
 
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13. The design and performance of each experimental procedure involving human subjects should 
be clearly formulated in an experimental protocol. This protocol should be submitted for 
consideration, comment, guidance, and where appropriate, approval to a specially appointed 
ethical review committee, which must be independent of the investigator, the sponsor or any other 
kind of undue influence. This independent committee should be in conformity with the laws and 
regulations of the country in which the research experiment is performed. The committee has the 
right to monitor ongoing trials. The researcher has the obligation to provide monitoring information 
to the committee, especially any serious adverse events. The 
researcher should also submit to the committee, for review, information regarding funding, 
sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects. 
14. The research protocol should always contain a statement of the ethical considerations involved 
and should indicate that there is compliance with the principles enunciated in this Declaration. 
15. Medical research involving human subjects should be conducted only by scientifically qualified 
persons and under the supervision of a clinically competent medical person. The responsibility for 
the human subject must always rest with a medically qualified person and never rest on the subject 
of the research, even though the subject has given consent. 
16. Every medical research project involving human subjects should be preceded by careful 
assessment of predictable risks and burdens in comparison with foreseeable benefits to the 
subject or to others. This does not preclude the participation of healthy volunteers in medical 
research. The design of all studies should be publicly available. 
17. Physicians should abstain from engaging in research projects involving human subjects unless 
they are confident that the risks involved have been adequately assessed and can be satisfactorily 
managed. Physicians should cease any investigation if the risks are found to outweigh the 
potential benefits or if there is conclusive proof of positive and beneficial results. 
18. Medical research involving human subjects should only be conducted if the importance of the 
objective outweighs the inherent risks and burdens to the subject. This is especially important 
when the human subjects are healthy volunteers. 
19. Medical research is only justified if there is a reasonable likelihood that the populations in 
which the research is carried out stand to benefit from the results of the research. 
20. The subjects must be volunteers and informed participants in the research project. 
21. The right of research subjects to safeguard their integrity must always be respected. Every 
precaution should be taken to respect the privacy of the subject, the confidentiality of the patient’s 
information and to minimize the impact of the study on the subject’s physical and mental integrity 
and on the personality of the subject. 
22. In any research on human beings, each potential subject must be adequately informed of the 
aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the 
researcher, the anticipated benefits and potential risks of the study and the discomfort it may 
entail. The subject should be informed of the right to abstain from participation in the study or to 
withdraw consent to participate at any time without reprisal. After ensuring that the subject has 
understood the information, the physician should then obtain the subject’s freely-given informed 
consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent 
must be formally documented and witnessed. 
23. When obtaining informed consent for the research project the physician should be particularly 
cautious if the subject is in a dependent relationship with the physician or may consent under 
duress. In that case the informed consent should be obtained by a well-informed physician who is 
not engaged in the investigation and who is completely independent of this relationship. 
24. For a research subject who is legally incompetent, physically or mentally incapable of giving 
consent or is a legally incompetent minor, the investigator must obtain informed consent from the 
legally authorized representative in accordance with applicable law. These groups should not be 
included in research unless the research is necessary to promote the health of the population 
represented and this research cannot instead be performed on legally competent persons. 
25. When a subject deemed legally incompetent, such as a minor child, is able to give assent to 
decisions about participation in research, the investigator must obtain that assent in addition to the 
consent of the legally authorized representative. 
26. Research on individuals from whom it is not possible to obtain consent, including proxy or 
advance consent, should be done only if the physical/mental condition that prevents obtaining 
informed consent is a necessary characteristic of the research population. The specific reasons for 
involving research subjects with a condition that renders them unable to give informed consent 

 
 
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should be stated in the experimental protocol for consideration and approval of the review 
committee. The protocol should state that consent to remain in the research should be obtained as 
soon as possible from the individual or a legally authorized surrogate. 
27. Both authors and publishers have ethical obligations. In publication of the results of research, 
the investigators are obliged to preserve the accuracy of the results. Negative as well as positive 
results should be published or otherwise publicly available. Sources of funding, institutional 
affiliations and any possible conflicts of interest should be declared in the publication. Reports of 
experimentation not in accordance with the principles laid down in this Declaration should not be 
accepted for publication. 
 
C. Additional principles for medical research combined with medical care 
28. The physician may combine medical research with medical care, only to the extent that the 
research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical 
research is combined with medical care, additional standards apply to protect the patients who are 
research subjects. 
29. The benefits, risks, burdens and effectiveness of a new method should be tested against those 
of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the 
use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic 
method exists. 
30. At the conclusion of the study, every patient entered into the study should be assured of 
access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. 
31. The physician should fully inform the patient which aspects of the care are related to the 
research. The refusal of a patient to participate in a study must never interfere with the patient–
physician relationship. 
32. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods 
do not exist or have been ineffective, the physician, with informed consent from the patient, must 
be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the 
physician’s judgement it offers hope of saving life, reestablishing health or alleviating suffering. 
Where possible, these measures should be made the object of research, designed to evaluate 
their safety and efficacy. In all cases, new information should be recorded and, where appropriate, 
published. The other relevant guidelines of this Declaration should be followed.