NCT04470349

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

July 8, 2020

Last Update Submit

January 25, 2023

Conditions

Proximal Interphalangeal Joint Fracture of the Hand

Outcome Measures

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)

    3 months after explantation

Secondary Outcomes (2)

  • Visual analogue scale (VAS) pain

    3 months after explantation

  • Functional assessment: Goniometry

    3 months after explantation

Study Arms (2)

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

LITOSDEVICE

Patients who received a LITOS dynamic distraction system after 31.12.2017

LITOS
LigamentotaxorDEVICE

Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017

Ligamentotaxor

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- additional fractures or disabilities of the hand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waldfriede Hospital

Berlin, 14163, Germany

RECRUITING

Study Officials

  • Markus Bock, MD

    Waldfriede Hospital

    PRINCIPAL INVESTIGATOR

  • Martin Lautenbach, MD

    Waldfriede Hospital

    STUDY CHAIR

Central Study Contacts

Markus Bock, MD

CONTACT

00493081810201m.bock@waldfriede.de

Matthias Url, MD

CONTACT

00493081810201m.url@waldfriede.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 14, 2020

Study Start

July 14, 2020

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

DE(1)