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

NCT04678622 | Completed DMC

• 1 other identifier: BIOFERULA3D
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Osteoarthritis of the Small Joints of the Hand

Keywords

Orthotic Devices; Biosplint 3D; Rhizarthrosis; Eaton-Littler I / II clasification; 3D technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 3D orthoses change functionality

  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.

  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 Outcomes (1)

• There are no relevant differences between the two orthoses in terms of fist force and clamp force.

  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).

Study Arms (2)

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

Interventions

Bioferula3D DEVICE

Custom splint with 3D technology classified as a custom medical device

3D Orthrosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optimus3D S.L.: lead
• Biobizkaia Health Research Institute: collaborator

Study Sites (2)

Optimus 3D S.L.

Vitoria-Gasteiz, Alava, 01510, Spain

Location

Hospital Universitario Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Related Publications (9)

• 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.

  PMID: 8923371 BACKGROUND

• 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.

  PMID: 20544159 BACKGROUND

• 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.

  PMID: 24821479 BACKGROUND

• 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.

  PMID: 4804988 BACKGROUND

• 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.

  PMID: 25534834 BACKGROUND

• 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.

  PMID: 11029559 BACKGROUND

• 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.

  PMID: 22918521 BACKGROUND

• 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.

  PMID: 25266241 BACKGROUND

• 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.

  PMID: 23458789 BACKGROUND

Study Officials

• Iñigo Cearra Guezuraga, IP

  Biobizkaia Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: July 27, 2018
• Primary Completion: August 27, 2018
• Study Completion: December 31, 2018
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)