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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Flexion Contracture of Proximal Interphalangeal Joint, Joint Deformities, Acquired

Intervention / Treatment
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* Device: ETDNO (Elastic Tension digital neoprene orthosis)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PIP flexion contracture Exclusion Criteria: more than 6 month of contracture and more than 45º of flexion contracture
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20-22 hours of daily TERT intervention<br>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)<br>* A bespoke orthosis created from neoprene.<br>|
| Active Comparator: 11-13 hours daily TERT intervention<br>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)<br>* A bespoke orthosis created from neoprene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extension improvement | The degree of extension of the PIP at the end of the treatment compared with the beginning | 3 weeks |