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Status unknownNCT04470349DYNAFIXUpdated Jan 26, 2023

Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

An observational study in Proximal Interphalangeal Joint Fracture of the Hand, sponsored by Waldfriede Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by Waldfriede Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Proximal Interphalangeal Joint Fracture of the Hand
03

In context

Lead sponsor

Waldfriede Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • additional fractures or disabilities of the hand
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • LITOS

    Patients who received a LITOS dynamic distraction system after 31.12.2017

    Device: LITOS

  • Ligamentotaxor

    Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017

    Device: Ligamentotaxor

Interventions

  • DeviceLITOS

    Patients who received a LITOS dynamic distraction system after 31.12.2017

  • DeviceLigamentotaxor

    Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 months after explantation

Secondary outcomes

  1. Visual analogue scale (VAS) pain

    From 0mm (no pain) to 100mm (maximum pain imaginable)

    Time frame: 3 months after explantation

  2. Functional assessment: Goniometry

    ROM of each joint of the injured fingert with a goniometer.

    Time frame: 3 months after explantation

07

Study locations

1 of 1 sites recruiting
  • Waldfriede Hospital
    Berlin, 14163, Germany
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2020 (actual). Primary completion is estimated for Dec 2023, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2020
First posted
Jul 14, 2020
StartActual
Jul 14, 2020
Primary completionEst.
Dec 31, 2023
CompletionEst.
Jun 30, 2024
Last update
Jan 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04470349
Lead sponsor
Waldfriede Hospital
Responsible party
Sponsor
First posted
Jul 14, 2020
Start date
Jul 14, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Jan 26, 2023

Study contacts

Markus Bock, MD
Contact
m.bock@waldfriede.de
00493081810201
Matthias Url, MD
Contact
m.url@waldfriede.de
00493081810201
Markus Bock, MD
principal investigator · Waldfriede Hospital
Martin Lautenbach, MD
study chair · Waldfriede Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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