Back to resultsEffective Treatment of Posttraumatic and Postoperative Edema
Primary Purpose
Edema
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ice gel pack
Multi-layer compression bandage
A-V Impulse compression
Sponsored by
About this trial
This is an interventional treatment trial for Edema focused on measuring edema reduction, ice, multi-layer compression bandage, A-V Impulse compression, ankle
Eligibility Criteria
Inclusion criteria:
- Age 18-65 years
- Inpatients
- Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)
- No walking aids before trauma
- Written informed consent
- Monotrauma
- Preoperative and/or postoperative edema
Preoperative inclusion
- if delay of surgery due to ankle edema
- if fracture stable enough for temporary removal of orthesis
Exclusion criteria:
- Diabetes Mellitus
- Lymphedema
- Peripheral arterial occlusive disease (PAD)
- Decompensated heart failure or renal insufficiency
- Acute bacterial infection
- Severe osteoporosis
- Pathological fractures
- Known tumors
- Postthrombotic syndrome
- Thrombosis
- Open fractures
- Polytrauma, cerebral trauma
- Neurological deficiencies
- Diuretics
- Pregnancy
- Alcohol or drug abuse
- Psychological disorders
Sites / Locations
- Luzerner Kantonsspital, Unfallchirurgie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Active Comparator
Arm Label
Control group
Multi-layer compression bandage
A-V Impulse compression
Arm Description
The Control group received ice gel packs and elevation to reduce edema.
A multi-layer compression bandage was applied to the lower limb and foot of the patient to reduce edema. Additionally, the limb was constantly elevated.
An A-V Impulse compression device was used to reduce edema.
Outcomes
Primary Outcome Measures
Ankle edema as measured with the figure-of-eight20 method
The figure-of-eight20 is a validated method to measure ankle edema with a simple spring tape. The spring tape follows a figure of eight around the ankle joint.
Secondary Outcome Measures
Pain scores measured on the Visual Analogue Scale (VAS)
Visual Analogue Scales were used to assess a daily pain score reflecting strongest and average pain perceived during the previous 24 hours, night pain and pain frequency.
Patient satisfaction with treatment scores measured on the Visual Analogue Scale
Visual Analogue Scales were used to assess patient satisfaction with the assigned treatment. The patients had to record their satisfaction with the treatment before surgery and after surgery.
Number of days until possible operation
The surgeon daily had to assess whether the patient was ready for operation or not. The wrinkling test served as a criteria for decision making. Accordingly the number of days until possible operation was recorded.
Number of postoperative hospitalization days
Postoperatively the physiotherapist each day had to record whether or not the patient was ready for discharge. Discharge criteria: 1. patient is able to walk 20 meters and one flight of stairs with crutches. 2. the wound is dry and not irritated. Accordingly, the number of days of postoperative hospitalization until discharge criteria were reached was recorded.
Range of motion of the ankle joint and foot.
Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer.
Amount of daily intake of medication
The intake of daily pain medication was recorded for the instay period (Dafalgan, Novalgin, opiates). Furthermore, the patient file was screened for any Nonsteroidal anti-inflammatory drugs (not allowed).
Number of adverse events as a measure of safety in each group
Adverse events were defined as:
bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism.
Lower limb function (Foot and ankle ability measure)
Questionnaire, self-assessed by the patient. To assess function and participation.
General Health (SF-36)
Generic assessment of the health status with the SF-36.
Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale
Patients had to record on the VAS on how satisfied they were with the overall outcome.
Amount of volumetric lower limb edema
Measurements of circumference of the lower limb were used to calculate lower limb volume. The circumferences of the lower limb were measured in increments of 4 cm from ankle level until below the knee joint.
Number of complains of discomfort or intolerances considering the intervention
Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances).
Full Information
NCT ID
NCT01389089
First Posted
June 23, 2011
Last Updated
October 3, 2023
Sponsor
Luzerner Kantonsspital
Collaborators
Orthofix Inc., Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT01389089
Brief Title
Effective Treatment of Posttraumatic and Postoperative Edema
Official Title
Effective Treatment of Posttraumatic and Postoperative Edema in Patients With Ankle- and Hindfoot Fractures. A Randomized Controlled Trial Comparing Multi-layer Compression Therapy and A-V Impulse Compression to the Standard Treatment With Ice
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luzerner Kantonsspital
Collaborators
Orthofix Inc., Medtronic - MITG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice.
Detailed Description
After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical intervention and may increases the risk of wound complications and infection postoperatively. Effective treatment of edema, therefore, is of great importance. The aim of this study was to evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment with ice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema
Keywords
edema reduction, ice, multi-layer compression bandage, A-V Impulse compression, ankle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The Control group received ice gel packs and elevation to reduce edema.
Arm Title
Multi-layer compression bandage
Arm Type
Experimental
Arm Description
A multi-layer compression bandage was applied to the lower limb and foot of the patient to reduce edema. Additionally, the limb was constantly elevated.
Arm Title
A-V Impulse compression
Arm Type
Active Comparator
Arm Description
An A-V Impulse compression device was used to reduce edema.
Intervention Type
Behavioral
Intervention Name(s)
ice gel pack
Intervention Description
ice gel pack combined with elevation
Intervention Type
Other
Intervention Name(s)
Multi-layer compression bandage
Other Intervention Name(s)
Artiflex, Comprilan
Intervention Description
Application of a multi-layer compression bandage to the foot and lower limb (two layers of wool followed by several layers of a short stretch bandage).
Intervention Type
Device
Intervention Name(s)
A-V Impulse compression
Other Intervention Name(s)
A-V intermittent Impulse compression device., AVI
Intervention Description
A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.
Primary Outcome Measure Information:
Title
Ankle edema as measured with the figure-of-eight20 method
Description
The figure-of-eight20 is a validated method to measure ankle edema with a simple spring tape. The spring tape follows a figure of eight around the ankle joint.
Time Frame
Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Secondary Outcome Measure Information:
Title
Pain scores measured on the Visual Analogue Scale (VAS)
Description
Visual Analogue Scales were used to assess a daily pain score reflecting strongest and average pain perceived during the previous 24 hours, night pain and pain frequency.
Time Frame
Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-ups at 6 weeks, 12 weeks and 1 year postoperative.
Title
Patient satisfaction with treatment scores measured on the Visual Analogue Scale
Description
Visual Analogue Scales were used to assess patient satisfaction with the assigned treatment. The patients had to record their satisfaction with the treatment before surgery and after surgery.
Time Frame
Participants were assessed for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative --> assessment at the day of discharge.
Title
Number of days until possible operation
Description
The surgeon daily had to assess whether the patient was ready for operation or not. The wrinkling test served as a criteria for decision making. Accordingly the number of days until possible operation was recorded.
Time Frame
Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.
Title
Number of postoperative hospitalization days
Description
Postoperatively the physiotherapist each day had to record whether or not the patient was ready for discharge. Discharge criteria: 1. patient is able to walk 20 meters and one flight of stairs with crutches. 2. the wound is dry and not irritated. Accordingly, the number of days of postoperative hospitalization until discharge criteria were reached was recorded.
Time Frame
Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days.
Title
Range of motion of the ankle joint and foot.
Description
Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer.
Time Frame
Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.
Title
Amount of daily intake of medication
Description
The intake of daily pain medication was recorded for the instay period (Dafalgan, Novalgin, opiates). Furthermore, the patient file was screened for any Nonsteroidal anti-inflammatory drugs (not allowed).
Time Frame
Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
Title
Number of adverse events as a measure of safety in each group
Description
Adverse events were defined as:
bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism.
Time Frame
Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Patient file was screened for adverse events until 1 year postoperatively.
Title
Lower limb function (Foot and ankle ability measure)
Description
Questionnaire, self-assessed by the patient. To assess function and participation.
Time Frame
12 weeks postoperative, 1 year postoperative.
Title
General Health (SF-36)
Description
Generic assessment of the health status with the SF-36.
Time Frame
12 weeks postoperative,1 year postoperative.
Title
Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale
Description
Patients had to record on the VAS on how satisfied they were with the overall outcome.
Time Frame
12 weeks and 1 year postoperative.
Title
Amount of volumetric lower limb edema
Description
Measurements of circumference of the lower limb were used to calculate lower limb volume. The circumferences of the lower limb were measured in increments of 4 cm from ankle level until below the knee joint.
Time Frame
Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Title
Number of complains of discomfort or intolerances considering the intervention
Description
Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances).
Time Frame
Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age 18-65 years
Inpatients
Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)
No walking aids before trauma
Written informed consent
Monotrauma
Preoperative and/or postoperative edema
Preoperative inclusion
if delay of surgery due to ankle edema
if fracture stable enough for temporary removal of orthesis
Exclusion criteria:
Diabetes Mellitus
Lymphedema
Peripheral arterial occlusive disease (PAD)
Decompensated heart failure or renal insufficiency
Acute bacterial infection
Severe osteoporosis
Pathological fractures
Known tumors
Postthrombotic syndrome
Thrombosis
Open fractures
Polytrauma, cerebral trauma
Neurological deficiencies
Diuretics
Pregnancy
Alcohol or drug abuse
Psychological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reto Babst, Prof.Dr.med.
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luzerner Kantonsspital, Unfallchirurgie
City
Luzern
ZIP/Postal Code
6000 16
Country
Switzerland
12. IPD Sharing Statement
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Effective Treatment of Posttraumatic and Postoperative Edema
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