Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
NCT ID: NCT04678622
Last Updated: 2020-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
39 participants
OBSERVATIONAL
2018-07-27
2018-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Classic Orthrosis
Group of patients who they will wear the usual splint indicated by the servicio physicians
No interventions assigned to this group
3D Orthrosis
Group of patients who they will wear the personalized splint designed by the company OPTIMUS 3D.
Bioferula3D
Custom splint with 3D technology classified as a custom medical device
Interventions
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Bioferula3D
Custom splint with 3D technology classified as a custom medical device
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Biocruces Bizkaia Health Research Institute
OTHER_GOV
Optimus3D S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Iñigo Cearra Guezuraga, IP
Role: PRINCIPAL_INVESTIGATOR
Biocruces Bizkaia Health Research Institute
Locations
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Optimus 3D S.L.
Vitoria-Gasteiz, Alava, Spain
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain
Countries
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References
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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.
Gomes 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.
Hirschfeld 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.
Eaton 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.
Spaans 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.
Barron 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.
Bani 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.
Hamann 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.
Chiu 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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BIOFERULA3D
Identifier Type: -
Identifier Source: org_study_id