Last reviewed · How we verify
NCT04678622
Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
trial testing Bioferula3D in Osteoarthritis of the Small Joints of the Hand in 39 participants. Completed in 31 December 2018.
27 August 2018
Quick facts
| Lead sponsor | Optimus3D S.L. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 39 |
| Start date | 27 July 2018 |
| Primary completion | 27 August 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Bioferula3D
Conditions studied
- Osteoarthritis of the Small Joints of the Hand — all drugs for Osteoarthritis of the Small Joints of the Hand →
Sponsor
Optimus3D S.L.
Who can join
Adults 18 to 75, any sex, with Osteoarthritis of the Small Joints of the Hand. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04678622
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04678622 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Optimus3D S.L.
- Last refreshed: 28 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04678622.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing