Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis

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).

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Small Joints of the Hand
• Intervention / Treatment: Device: Bioferula3D

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria, Alava, Spain, 01510
      • Optimus 3D S.L.
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Bioferula3D; Custom splint with 3D technology classified as a custom medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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?	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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
There are no relevant differences between the two orthoses in terms of fist force and clamp force.	By gripping force, using a dynamometer in the consultation.	It 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).

Collaborators and Investigators

• Sponsor: Optimus3D S.L.
• Collaborators: Biocruces Bizkaia Health Research Institute
• Investigators: Principal Investigator: Iñigo Cearra Guezuraga, IP, Biocruces Bizkaia Health Research Institute

Publications and helpful links

General 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.
• 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, Avon). 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2018
• Primary Completion (ACTUAL): August 27, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Rhizarthrosis; Orthotic Devices; Biosplint 3D; Eaton-Littler I / II clasification; 3D technology
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: BIOFERULA3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No