Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

Recruiting

• Conditions: Proximal Interphalangeal Joint Fracture of the Hand

• 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

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study Start: 2020-07-14
• Study First Posted: 2020-07-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

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

Primary Outcome Measures

Name	Time	Method
Disabilities of Arm, Shoulder and Hand (DASH) score	3 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

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

Trial Locations

Locations (1)

Waldfriede Hospital; 🇩🇪 Berlin, Germany