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

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

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.

Study Overview

• Status: Completed
• Conditions: Joint Deformities, Acquired; Flexion Contracture of Proximal Interphalangeal Joint
• Intervention / Treatment: Device: ETDNO (Elastic Tension digital neoprene orthosis)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08010
      • Hand Therapy Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PIP flexion contracture

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20-22 hours of daily TERT intervention; 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.
Active Comparator: 11-13 hours daily TERT intervention; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vicenç Punsola Izard
• Investigators: Principal Investigator: Vicenç Punsola-Izard, Hand Therapy Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Contracture; Joint Deformities, Acquired
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: will be available in the papers published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No