An interventional study of ETDNO (Elastic Tension digital neoprene orthosis) in Flexion Contracture of Proximal Interphalangeal Joint and Joint Deformities, Acquired, sponsored by Vicenç Punsola Izard. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Vicenç Punsola Izard · Not applicable, Interventional, and Treatment
Introduction: Flexion contracture is one of the most frequent complications in finger trauma. The use of orthoses to obtain the best total end range time (TERT) is the most popular method to treat this pathology . Until now, no orthosis applied for longer than 3 weeks had been able to achieve TERT longer than 12 hours.
Purpose of the study: To assess whether the elastic tension digital neoprene orthosis (ETDNO), using a serial dynamic program, can achieve a better result in ROM and TERT than other orthoses described in the literature.
Methods: analysis of outcomes in a sample of 30 patients with PIP joint flexion contracture treated with the ETDNO and serial dynamic program.
In this study the researcher will compare the efect of daily TERT treatment on the proximal interphalangeal joint contracture using an ETDNO. The investigator will treat two different groups one with a dose of from 11 to 13 hours of the ETDNO while the other one is treated with a dose of from 20 to 22 hours of daily TERT with the same device. This treatment will last three weeks and will be evalauted the first day, the he first week and the third week. At the end of the study the researcher will quantify the improvement on both groups to know which dailyTERT dose is the best option.
Vicenç Punsola Izard is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks.
Device: ETDNO (Elastic Tension digital neoprene orthosis)
Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks.
Device: ETDNO (Elastic Tension digital neoprene orthosis)
A bespoke orthosis created from neoprene.
Extension improvement
The degree of extension of the PIP at the end of the treatment compared with the beginning
Time frame: 3 weeks
Plan to share: No — will be available in the papers published
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Joint Deformities, Acquired
Vicenç Punsola Izard