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

NCT04678622 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2020-12-28

No results posted yet for this study

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

Interventions

DEVICE

Bioferula3D

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

Sponsors & Collaborators

  • Biocruces Bizkaia Health Research Institute

    collaborator OTHER_GOV

  • Optimus3D S.L.

    lead INDUSTRY

Principal Investigators

  • Iñigo Cearra Guezuraga, IP · Biocruces Bizkaia Health Research Institute

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2018-08-27
Completion
2018-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678622 on ClinicalTrials.gov