Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

Proximal Interphalangeal Joint Fracture of the Hand Clinical Trial

— DYNAFIX  

Official title:

Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470349
• Other study ID #: 2020.1
• Status: Recruiting
• Start date: July 14, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Waldfriede Hospital
• Contact: Markus Bock, MD
• Phone: 00493081810201
• Email: m.bock[@]waldfriede.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fractures of the proximal interphalangeal joints continue to pose significant management challenges. Thus the aim of our study is to compare two dynamic finger joint distractors (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination and functional assessments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• proximal interphalangeal fracture treated with external dynamic fixator
• Operative care <21 days from trauma
• Age between 18 and 90 years.
• Male and female

Exclusion Criteria:

• additional fractures or disabilities of the hand

Related Conditions & MeSH terms

• Fractures, Bone
• Proximal Interphalangeal Joint Fracture of the Hand

Intervention

Device:
• LITOS
Patients who received a LITOS dynamic distraction system after 31.12.2017
• Ligamentotaxor
Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017

Locations

Country	Name	City	State
Germany	Waldfriede Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Waldfriede Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of Arm, Shoulder and Hand (DASH) score	Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)	3 months after explantation
Secondary	Visual analogue scale (VAS) pain	From 0mm (no pain) to 100mm (maximum pain imaginable)	3 months after explantation
Secondary	Functional assessment: Goniometry	ROM of each joint of the injured fingert with a goniometer.	3 months after explantation