Effective Treatment of Posttraumatic and Postoperative Edema

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01389089
• Date of registration: 23/06/2011
• Primary sponsor: Luzerner Kantonsspital
• Public title: Effective Treatment of Posttraumatic and Postoperative Edema
• Scientific 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
• Date of first enrolment: January 2007
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01389089
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Switzerland

Contacts

• Name: Reto Babst, Prof.Dr.med.
• Affiliation: Luzerner Kantonsspital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Edema

Intervention(s)

Device: A-V Impulse compression

Other: ice gel pack

Other: Multi-layer compression bandage

Primary Outcome(s)

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.]

Secondary Outcome(s)

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.]

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.]

General Health (SF-36) [Time Frame: 12 weeks postoperative,1 year postoperative.]

Lower limb function (Foot and ankle ability measure) [Time Frame: 12 weeks postoperative, 1 year postoperative.]

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.]

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.]

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.]

Number of postoperative hospitalization days [Time Frame: Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days.]

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.]

Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale [Time Frame: 12 weeks and 1 year postoperative.]

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.]

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.]

Secondary ID(s)

616

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Covidien

Orthofix Inc.