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Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

Recruiting
Conditions
Proximal Interphalangeal Joint Fracture of the Hand
Interventions
Device: LITOS
Device: Ligamentotaxor
Registration Number
NCT04470349
Lead Sponsor
Waldfriede Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
LITOSLITOSPatients who received a LITOS dynamic distraction system after 31.12.2017
LigamentotaxorLigamentotaxorPatients who received a Ligamentotaxor dynamic distraction system after 31.12.2017
Primary Outcome Measures
NameTimeMethod
Disabilities of Arm, Shoulder and Hand (DASH) score3 months after explantation

Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)

Secondary Outcome Measures
NameTimeMethod
Functional assessment: Goniometry3 months after explantation

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

Visual analogue scale (VAS) pain3 months after explantation

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

Trial Locations

Locations (1)

Waldfriede Hospital

🇩🇪

Berlin, Germany

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