Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures (DYNAFIX)

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.

Study Overview

• Status: Recruiting
• Conditions: Proximal Interphalangeal Joint Fracture of the Hand
• Intervention / Treatment: Device: LITOS; Device: Ligamentotaxor

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Markus Bock, MD; Phone Number: 00493081810201; Email: m.bock@waldfriede.de
• Study Contact Backup: Name: Matthias Url, MD; Phone Number: 00493081810201; Email: m.url@waldfriede.de

Study Locations

• Germany
  • Berlin, Germany, 14163
    • Recruiting
    • Waldfriede Hospital
    • Contact: Markus Bock, MD; Phone Number: 00493081810201; Email: m.bock@waldfriede.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who have sustained a proximal interphalangeal fracture treated with external dynamic fixator

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LITOS; Patients who received a LITOS dynamic distraction system after 31.12.2017	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	Device: Ligamentotaxor; Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) pain	From 0mm (no pain) to 100mm (maximum pain imaginable)	3 months after explantation
Functional assessment: Goniometry	ROM of each joint of the injured fingert with a goniometer.	3 months after explantation

Collaborators and Investigators

• Sponsor: Waldfriede Hospital
• Investigators: Principal Investigator: Markus Bock, MD, Waldfriede Hospital; Study Chair: Martin Lautenbach, MD, Waldfriede Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2020.1

Drug and device information, study documents

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