Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-30 @ 1:23 AM
Study NCT ID:
NCT05465603
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2022-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:
Sponsor:
Vicenç Punsola Izard
Organization:
Study Overview
Official Title:
Rationale for the Use of Elastic Tension Digital Neoprene Orthoses in the Treatment of Proximal Interphalangeal Joint Flexion Contracture: Long Term Results
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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:
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: