Vascular Impulse Technology versus elevation in the treatment of posttraumatic swelling of extremity fractures: VIT Study - a prospective, randomized, controlled clinical trial

Phase 4

• Conditions: S53.18; S42.49; S42.21; S92.0; S82.5; S82.81; S82.28; S82.18; S52.51; S52.52

• Registration Number: DRKS00010510
• Lead Sponsor: BG Klinik Ludwigshafen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-18
• Study Completion: 2019-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Age 18 to 80 years

inpatient treatment

written informed consent

operative treatment of one of the following injuries:

Calcaneal fracture
Tibial pilon fracture (Type B/C AO)
Ankle fracture
Tibia shaft fracture
Tibial head fracture (Type B/C AO)
distal radius fracture (Type C AO)
elbow dislocation
distal humerus fracture (Type B/C AO)
proximal humerus fracture

Exclusion Criteria

Age <18 or >80 years
both sides of the upper or lower extremity injured
open fractures
infection of the involved extremity
missing informed consent
severe heart insuffiency
acute phlebitis
acute thrombosis or pulmonary embolism
lokal wound problems such as nekrosis
drug abuse
prisoner
participation in another clinical trial
pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from injury taken for swelling to resolve sufficiently to permit surgery.

Secondary Outcome Measures

Name	Time	Method
Daily measurement of the girth of the injured and the uninjured contralateral extremity<br><br>daily documentation of pain level (Visual Analog Scale)<br><br>daily documentation of pain medication<br><br>time needed for instruction of the VADOPlex System (min)<br><br>Frequency and time needed for additional instructions of the VADOPlex System<br><br>Duration of the hospital stay (days)<br><br>Documentation of perioperative complications until the final follow-up<br><br>Usability of the VADO-Plex System<br><br>Cost analysis (material, pads) of the VADOPlex System compared to conventional methods