Trial document




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  DRKS00010510

Trial Description

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Title

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

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Trial Acronym

VIT-Study

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URL of the Trial

http://none

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Brief Summary in Lay Language

Fractures of the upper and lower extremity are often complicated by a variable degree of swelling of the surrounding soft tissue. Many of these fractures develop severe swelling that precludes operative intervention until adequate edema resolution has commenced. Patients typically require up to 7 days of inpatient bed-rest and elevation to reduce swelling to an acceptable level for operative treatment with internal fixation. Alternatively, a Vasular-Impulse-Technology (VIT)-system can be used at the injured leg. The VIT-system is comprised of a pneumatic compressor that intermittently rapidly inflates a bladder positioned under the arch of the foot or the hand.

In the current study the VIT-system will be compared with conventional methods (ice and elevation) in the treatment of posttraumatic swelling of the upper and lower extremity.

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Brief Summary in Scientific Language

Fractures of the upper and the lower extremity are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury. Many of these fractures develop severe swelling that precludes operative intervention until adequate edema resolution has commenced. Patients typically require up to 7 days of inpatient bed-rest and elevation to reduce swelling to an acceptable level for operative treatment with internal fixation. Postoperatively, swelling of the soft tissue is often responsible for local wound complications leading to necrosis of the skin. In addition, the perioperative swelling of the soft tissue is accompanied by pain leading to prolonged immobilization and higher pain medication with associated complications.
Delay in surgery impacts the patient in the short-term but also increases the burden on an orthopaedic in-patient trauma unit by prolonging the pre-operative interval and total hospital stay.
Numerous interventions have been developed to control softtissue swelling including elevation, compressive dressings and splint immobilization. More recently, cryotherapy and pulsatile compressive devices have been employed. Several studies have shown each of these to be effective in reducing oedema faster than simple elevation and immobilization.
The use of A-V impulse devices such as the VADOPlex-System has previously been shown to reduce oedema by means of measurement of ankle and toe girths. The clinical advantages of these devices have not been investaged in detail, complications such as postoperative skin nekrosis, compartment syndrome and amount of pain medication have not been determined.
The primary outcome parameter of this trial is the time taken for swelling to resolve sufficiently to permit surgery. We hypothesized, that the VADOPlex-System will reduce time from injury to surgery compared to conventional methods (elevation) to 2 days. Secondarily, the pain level, pain medication, girth measurements and complications associated with the soft tissue swelling will be determined.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010510
  •   2016/07/18
  •   [---]*
  •   yes
  •   Approved
  •   837.155.16 (10474), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   S92.0 -  Fracture of calcaneus
  •   S82.5 -  Fracture of medial malleolus
  •   S82.81 -  [generalization S82.8: Fractures of other parts of lower leg]
  •   S82.28 -  [generalization S82.2: Fracture of shaft of tibia]
  •   S82.18 -  [generalization S82.1: Fracture of upper end of tibia]
  •   S52.51 -  [generalization S52.5: Fracture of lower end of radius]
  •   S52.52 -  [generalization S52.5: Fracture of lower end of radius]
  •   S53.18 -  [generalization S53.1: Dislocation of elbow, unspecified]
  •   S42.49 -  [generalization S42.4: Fracture of lower end of humerus]
  •   S42.21 -  [generalization S42.2: Fracture of upper end of humerus]
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Interventions/Observational Groups

  •   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
  •   In the control group conventional methods such as elevation of the injured arm or leg will be performed.

    pre-operatively: 24h/day
    post-operatively: depending on soft-tissue conditions
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/08/20
  •   280
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional 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

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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

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Addresses

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    • BG Klinik Ludwigshafen
    • Mr.  Dr. med.  Jochen  Franke 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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    • BG Klinik Ludwigshafen
    • Mr.  Dr. med.  Marc  Schnetzke 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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    • BG Klinik Ludwigshafen
    • Ms.  Carina  Poh 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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Sources of Monetary or Material Support

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    • OPED GmbH
    • Mr.  Jörg  Schröder 
    • Medizinpark 1
    • 83626  Valley/Oberlaindern
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/03/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.