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Completed

NCT Number: NCT01389089

Effective Treatment of Posttraumatic and Postoperative Edema

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.

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Key information

Conditions

Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luzerner Kantonsspital, Unfallchirurgie

Lucerne, 6000 16, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ice gel pack

Behavioral

ice gel pack combined with elevation

Multi-layer compression bandage

Other

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).

Other names: Artiflex, Comprilan

A-V Impulse compression

Device

A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.

Other names: A-V intermittent Impulse compression device., AVI

Primary outcomes

  1. Ankle edema as measured with the figure-of-eight20 method

    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.

    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 outcomes

  1. Pain scores measured on the Visual Analogue Scale (VAS)

    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.

    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.

  2. Patient satisfaction with treatment scores measured on the Visual Analogue Scale

    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.

    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.

  3. Number of days until possible operation

    Time frame: Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.

    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.

  4. Number of postoperative hospitalization days

    Time frame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 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.

  5. Range of motion of the ankle joint and foot.

    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.

    Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer.

  6. Amount of daily intake of medication

    Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.

    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).

  7. Number of adverse events as a measure of safety in each group

    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.

    Adverse events were defined as:

    bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism.

  8. Lower limb function (Foot and ankle ability measure)

    Time frame: 12 weeks postoperative, 1 year postoperative.

    Questionnaire, self-assessed by the patient. To assess function and participation.

  9. General Health (SF-36)

    Time frame: 12 weeks postoperative,1 year postoperative.

    Generic assessment of the health status with the SF-36.

  10. Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale

    Time frame: 12 weeks and 1 year postoperative.

    Patients had to record on the VAS on how satisfied they were with the overall outcome.

  11. Amount of volumetric lower limb edema

    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.

    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.

  12. Number of complains of discomfort or intolerances considering the intervention

    Time frame: Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.

    Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances).

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Collaborators

  • Medtronic - MITG
  • Orthofix Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jul 7, 2011
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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