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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05465603
Enrollment
60
Registered
2022-07-20
Start date
2022-07-01
Completion date
2022-12-14
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flexion Contracture of Proximal Interphalangeal Joint, Joint Deformities, Acquired

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.

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.

Interventions

DEVICEETDNO (Elastic Tension digital neoprene orthosis)

A bespoke orthosis created from neoprene.

Sponsors

Vicenç Punsola Izard
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Patients do not know which dose they are reciving compared to the other group

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* PIP flexion contracture

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Extension improvement3 weeksThe degree of extension of the PIP at the end of the treatment compared with the beginning

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026