S92.0 S82.5 S82.81 S82.28 S82.18 S52.51 S52.52 S53.18 S42.49 S42.21
Conditions
Interventions
Group 1: VADOPlex-group: patients within this group receive the VADOPlex system on the injured arm or leg to reduce the swelling.
pre-operatively: 24h/day
post-operatively: 6-8h/day
Group 2: In the c
Sponsors
BG Klinik Ludwigshafen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
Exclusion criteria: Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from injury taken for swelling to resolve sufficiently to permit surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily measurement of the girth of the injured and the uninjured contralateral extremity daily documentation of pain level (Visual Analog Scale) daily documentation of pain medication time needed for instruction of the VADOPlex System (min) Frequency and time needed for additional instructions of the VADOPlex System Duration of the hospital stay (days) Documentation of perioperative complications until the final follow-up Usability of the VADO-Plex System Cost analysis (material, pads) of the VADOPlex System compared to conventional methods | — |
Countries
Germany
Contacts
Public ContactCarina Poh
BG Klinik Ludwigshafen
Outcome results
None listed