Status:

COMPLETED

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

Lead Sponsor:

Optimus3D S.L.

Collaborating Sponsors:

Biocruces Bizkaia Health Research Institute

Conditions:

Osteoarthritis of the Small Joints of the Hand

Eligibility:

All Genders

18-75 years

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 (Stage...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 27 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2018

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT04678622

Start Date

July 27 2018

End Date

December 31 2018

Last Update

December 28 2020

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Optimus 3D S.L.

Vitoria-Gasteiz, Alava, Spain, 01510

2

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain, 48013