Osteoarthritis of the Small Joints of the HandNCT04678622
Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
An observational study of Osteoarthritis of the Small Joints of the Hand, run by Optimus3D S.L. at 2 sites in Spain.
Trial summary
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger joints and it is a major cause of disability. Radiology and the Eaton-Littler classification (Stages I-II-III-IV) are used for its diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Small Joints of the Hand
- What is being tested?
- Bioferula3D
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 2 sitesSpain
- Study dates
- 27 Jul 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint
Who may be able to join
- Clinical diagnosis of osteoarthritis of the trapeziometacarpal joint.
- Radiological stage of Eaton-Littler classification I / II.
- Patients in whom the placement of a discharge splint is clinically indicated.
- Score between 3 and 7 on the VAS pain scale (range 0 to 10).
Who cannot join
- Previous treatment of osteoarthritis of the trapeziometacarpal joint.
- Refuses to participate in the study.
- Disabilities that prevent the completion of the questionnaires.
- Presence of severe deformations in the hand.
- Presence of other alterations, such as carpal tunnel syndrome, tendonitis or chronic inflammatory arthropathies.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Basurto
Bilbao, Vizcaya, 48013
Optimus 3D S.L.
Vitoria-Gasteiz, Alava, 01510
About this study
Official title: Proof of Concept: Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger joints and it is a major cause of disability. Radiology and the Eaton-Littler classification (Stages I-II-III-IV) are used for its diagnosis. The treatment of stages I, II and in some cases of stage III, is based on pharmacological and rehabilitation measures, including the use of orthoses or splints.
The development of Biosplint 3D will allow a qualitative leap forward in the search for an intelligent solution for patients with rhizarthrosis (Degenerative alteration of the trapezius-metacarpal joint (TMJ) characterized by a progressive deterioration of the articular surfaces and new bone formation in them).
Read more
The aim of the study is to assess the feasibility of applying a personalized splint versus a conventional one. 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.
The study includes a recruitment visit and two follow-up visits, one at a month and a final visit at 3 months. Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint are included. One group of patients wears the usual splint indicated by the personalized doctors of the Service and the other group wears the 3D bi-splint.
The main variable is pain, which will be measured by a visual analog scale (VAS). In addition, the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand) and questions about patient satisfaction with the use of splints will be used.
Read the detailed description
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%. Its diagnosis is basically clinical, although radiological tests are very useful to confirm it and to typify the evolution of the disease.
The TMJ has a great range of mobility, since it basically serves to oppose the thumb to the rest of the fingers and to 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. 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 pincer movements.
- Conventional orthoses
Currently there are several types of splints on the market 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 is not heated, it may not thermoform well.
- You cannot make rectifications, so you have to be careful with the mold and 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 is their instability in immobilization: they do not hold firmly, since they do not fit perfectly to the affected area.
- Advantages of the 3D bioferula
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.
- Water resistance, 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.
- Being tested
- Bioferula3D
- Keywords
- Orthotic Devices, Biosplint 3D, Rhizarthrosis, Eaton-Littler I / II clasification, 3D technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioferula3DDevice
Custom splint with 3D technology classified as a custom medical device
| Study group | Role | What they receive |
|---|---|---|
| Classic Orthrosis | Group of patients who they will wear the usual splint indicated by the servicio physicians | |
| 3D Orthrosis | Group of patients who they will wear the personalized splint designed by the company OPTIMUS 3D. Receives: Device: Bioferula3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured: Change of pain in patients with clasic orthrosis compared to the orthrosis designed using 3D technology
By visual analog scale from 0 (no pain) to 10 (unbereable pain)
Measured: Pain measurement by visual analog scale is performed at the baseline visit, at the second visit (one month later) and at the third follow-up visit (end of the study) which will take place at the third month of follow-up (between 11-14 weeks).
Secondary outcomes (2)
3D orthoses change functionality
By DASH (10) scale consists of 30 items. In addition, there are 2 optional modules, with 4 items each one of them, that will 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 is added to obtain a total score, which can range between 30 and 150 points and which is transformed into a scale from 0 (best possible score) to 100 (worst possible score).
The DASH scale 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.
Measured: Functionality is performed at the baseline visit, at the second visit (one month after) and at the third follow-up visit (end of the study), which will take place at the third month of follow-up (between 11-14 weeks).
Satisfaction and compliance are equally superior in the 3D orthosis.
By satisfaction scale composed of 6 items (each of them scored from 0 to 10):
- What is your level of satisfaction with the splint?
- Has the splint helped decrease your pain?
- Has the splint helped you maintain your daily activities?
- Has your quality of life improved?
- How comfortable was the use of the splint?
- How easy was it to follow the instructions for using the splint?
Measured: Satisfaction is performed at the second visit (one month after) and at the third follow-up visit (end of the study), which will take place at the third month of follow-up (between 11-14 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start27 Jul 2018
- Primary completion27 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the Small Joints of the HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimus3D S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biobizkaia Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Iñigo Cearra Guezuraga, IP, Principal investigator, Biobizkaia Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678622
- Sponsor's protocol ID
- BIOFERULA3D
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooper C, Egger P, Coggon D, Hart DJ, Masud T, Cicuttini F, Doyle DV, Spector TD. Generalized osteoarthritis in women: pattern of joint involvement and approaches to definition for epidemiological studies. J Rheumatol. 1996 Nov;23(11):1938-42.
PubMed 8923371Gomes Carreira AC, 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. 2010 May;42(5):469-74. doi: 10.2340/16501977-0542.
PubMed 20544159Hirschfeld M, Galan A, Arenas J, Del Aguila B, Benitez-Parejo N, Costa JA, Guerado E. [Inter-observer agreement on the Eaton-Littler classification of trapeziometacarpal joint osteoarthritis]. Rev Esp Cir Ortop Traumatol. 2014 Jul-Aug;58(4):237-41. doi: 10.1016/j.recot.2014.01.006. Epub 2014 May 10. Spanish.
PubMed 24821479Eaton RG, Littler JW. Ligament reconstruction for the painful thumb carpometacarpal joint. J Bone Joint Surg Am. 1973 Dec;55(8):1655-66. No abstract available.
PubMed 4804988Spaans AJ, van Minnen LP, Kon M, Schuurman AH, Schreuders AR, Vermeulen GM. Conservative treatment of thumb base osteoarthritis: a systematic review. J Hand Surg Am. 2015 Jan;40(1):16-21.e1-6. doi: 10.1016/j.jhsa.2014.08.047.
PubMed 25534834Barron OA, Glickel SZ, Eaton RG. Basal joint arthritis of the thumb. J Am Acad Orthop Surg. 2000 Sep-Oct;8(5):314-23. doi: 10.5435/00124635-200009000-00005.
PubMed 11029559Bani MA, Arazpour M, Kashani RV, Mousavi ME, Maleki M, Hutchins SW. The effect of custom-made splints in patients with the first carpometacarpal joint osteoarthritis. Prosthet Orthot Int. 2013 Apr;37(2):139-44. doi: 10.1177/0309364612454047. Epub 2012 Aug 22.
PubMed 22918521Hamann N, Heidemann J, Heinrich K, Wu H, Bleuel J, Gonska C, Bruggemann GP. Stabilization effectiveness and functionality of different thumb orthoses in female patients with first carpometacarpal joint osteoarthritis. Clin Biomech (Bristol). 2014 Dec;29(10):1170-6. doi: 10.1016/j.clinbiomech.2014.09.007. Epub 2014 Sep 19.
PubMed 25266241Chiu NF, Huang TY, Kuo CC, Lin CW, Lee JH. Organic-based plasmonic emitters for sensing applications. Appl Opt. 2013 Mar 1;52(7):1383-8. doi: 10.1364/AO.52.001383.
PubMed 23458789
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept: Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
- ClinicalTrials.gov ID
- NCT04678622
- Acronym / sponsor ID
- BIOFERULA3D
- Keywords
- Orthotic Devices, Biosplint 3D, Rhizarthrosis, Eaton-Littler I / II clasification, 3D technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Optimus3D S.L.Industry (pharma, biotech, devices)
- Collaborators
- Biobizkaia Health Research Institute
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger joints and it is a major cause of disability. Radiology and the Eaton-Littler classification (Stages I-II-III-IV) are used for its diagnosis. The treatment of stages I, II and in some cases of stage III, is based on pharmacological and rehabilitation measures, including the use of orthoses or splints.
The development of Biosplint 3D will allow a qualitative leap forward in the search for an intelligent solution for patients with rhizarthrosis (Degenerative alteration of the trapezius-metacarpal joint (TMJ) characterized by a progressive deterioration of the articular surfaces and new bone formation in them).
The aim of the study is to assess the feasibility of applying a personalized splint versus a conventional one. 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.
The study includes a recruitment visit and two follow-up visits, one at a month and a final visit at 3 months. Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint are included. One group of patients wears the usual splint indicated by the personalized doctors of the Service and the other group wears the 3D bi-splint.
The main variable is pain, which will be measured by a visual analog scale (VAS). In addition, the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand) and questions about patient satisfaction with the use of splints will be used.
Detailed description
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%. Its diagnosis is basically clinical, although radiological tests are very useful to confirm it and to typify the evolution of the disease.
The TMJ has a great range of mobility, since it basically serves to oppose the thumb to the rest of the fingers and to 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. 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 pincer movements.
- Conventional orthoses
Currently there are several types of splints on the market 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 is not heated, it may not thermoform well.
- You cannot make rectifications, so you have to be careful with the mold and 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 is their instability in immobilization: they do not hold firmly, since they do not fit perfectly to the affected area.
- Advantages of the 3D bioferula
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.
- Water resistance, 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic Orthrosis | – | –Group of patients who they will wear the usual splint indicated by the servicio physicians |
| 3D Orthrosis | – | Device: Bioferula3DGroup of patients who they will wear the personalized splint designed by the company OPTIMUS 3D. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint
Key inclusion criteria (4 listed)
- Clinical diagnosis of osteoarthritis of the trapeziometacarpal joint.
- Radiological stage of Eaton-Littler classification I / II.
- Patients in whom the placement of a discharge splint is clinically indicated.
- Score between 3 and 7 on the VAS pain scale (range 0 to 10).
Key exclusion criteria (5 listed)
- Previous treatment of osteoarthritis of the trapeziometacarpal joint.
- Refuses to participate in the study.
- Disabilities that prevent the completion of the questionnaires.
- Presence of severe deformations in the hand.
- Presence of other alterations, such as carpal tunnel syndrome, tendonitis or chronic inflammatory arthropathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioferula3DCustom splint with 3D technology classified as a custom medical device | Device | 3D Orthrosis |
Primary outcome
Pain measured: Change of pain in patients with clasic orthrosis compared to the orthrosis designed using 3D technology
Time frame: Pain measurement by visual analog scale is performed at the baseline visit, at the second visit (one month later) and at the third follow-up visit (end of the study) which will take place at the third month of follow-up (between 11-14 weeks).
By visual analog scale from 0 (no pain) to 10 (unbereable pain)
2 secondary outcomes
3D orthoses change functionality
Time frame: Functionality is performed at the baseline visit, at the second visit (one month after) and at the third follow-up visit (end of the study), which will take place at the third month of follow-up (between 11-14 weeks).
Satisfaction and compliance are equally superior in the 3D orthosis.
Time frame: Satisfaction is performed at the second visit (one month after) and at the third follow-up visit (end of the study), which will take place at the third month of follow-up (between 11-14 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Background: PubMed 8923371Cooper C, Egger P, Coggon D, Hart DJ, Masud T, Cicuttini F, Doyle DV, Spector TD. Generalized osteoarthritis in women: pattern of joint involvement and approaches to definition for epidemiological studies. J Rheumatol. 1996 Nov;23(11):1938-42.
- Background: PubMed 20544159Gomes Carreira AC, 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. 2010 May;42(5):469-74. doi: 10.2340/16501977-0542.
- Background: PubMed 24821479Hirschfeld M, Galan A, Arenas J, Del Aguila B, Benitez-Parejo N, Costa JA, Guerado E. [Inter-observer agreement on the Eaton-Littler classification of trapeziometacarpal joint osteoarthritis]. Rev Esp Cir Ortop Traumatol. 2014 Jul-Aug;58(4):237-41. doi: 10.1016/j.recot.2014.01.006. Epub 2014 May 10. Spanish.
- Background: PubMed 4804988Eaton RG, Littler JW. Ligament reconstruction for the painful thumb carpometacarpal joint. J Bone Joint Surg Am. 1973 Dec;55(8):1655-66. No abstract available.
- Background: PubMed 25534834Spaans AJ, van Minnen LP, Kon M, Schuurman AH, Schreuders AR, Vermeulen GM. Conservative treatment of thumb base osteoarthritis: a systematic review. J Hand Surg Am. 2015 Jan;40(1):16-21.e1-6. doi: 10.1016/j.jhsa.2014.08.047.
- Background: PubMed 11029559Barron OA, Glickel SZ, Eaton RG. Basal joint arthritis of the thumb. J Am Acad Orthop Surg. 2000 Sep-Oct;8(5):314-23. doi: 10.5435/00124635-200009000-00005.
- Background: PubMed 22918521Bani MA, Arazpour M, Kashani RV, Mousavi ME, Maleki M, Hutchins SW. The effect of custom-made splints in patients with the first carpometacarpal joint osteoarthritis. Prosthet Orthot Int. 2013 Apr;37(2):139-44. doi: 10.1177/0309364612454047. Epub 2012 Aug 22.
- Background: PubMed 25266241Hamann N, Heidemann J, Heinrich K, Wu H, Bleuel J, Gonska C, Bruggemann GP. Stabilization effectiveness and functionality of different thumb orthoses in female patients with first carpometacarpal joint osteoarthritis. Clin Biomech (Bristol). 2014 Dec;29(10):1170-6. doi: 10.1016/j.clinbiomech.2014.09.007. Epub 2014 Sep 19.
- Background: PubMed 23458789Chiu NF, Huang TY, Kuo CC, Lin CW, Lee JH. Organic-based plasmonic emitters for sensing applications. Appl Opt. 2013 Mar 1;52(7):1383-8. doi: 10.1364/AO.52.001383.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iñigo Cearra Guezuraga, IP principal investigator
Biobizkaia Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Small Joints of the Hand, run by Optimus3D S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured: Change of pain in patients with clasic orthrosis compared to the orthrosis designed using 3D technology (time frame: Pain measurement by visual analog scale is performed at the baseline visit, at the second visit (one month later) and at the third follow-up visit (end of the study) which will take place at the third month of follow-up (between 11-14 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678622, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.