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Completed

NCT Number: NCT05465603

Rationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:

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.

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Key information

Conditions

Flexion Contracture of Proximal Interphalangeal Joint Joint Deformities, Acquired Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hand Therapy Barcelona

Barcelona, Catalonia, 08010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PIP flexion contracture

Exclusion criteria

  • more than 6 month of contracture and more than 45º of flexion contracture

Treatment and study plan

ETDNO (Elastic Tension digital neoprene orthosis)

Device

A bespoke orthosis created from neoprene.

Primary outcomes

  1. Extension improvement

    Time frame: 3 weeks

    The degree of extension of the PIP at the end of the treatment compared with the beginning

Sponsors and collaborators

Lead sponsor

Vicenç Punsola Izard

Other

Registry information

Official study title

Rationale for the Use of Elastic Tension Digital Neoprene Orthoses in the Treatment of Proximal Interphalangeal Joint Flexion Contracture: Long Term Results

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2022
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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