Knee Swelling Under Use of Compression Stockings After Outpatient Surgery

May 23, 2016 updated by: Sebastian Oye, University of Rostock

Prospective Randomized Assessment of Postsurgical Swelling Applying Compression Stockings vs. Conventional Wrapping After Outpatient Surgery

Outpatients who undergo knee surgery are designated two different clinical study groups. Group A receives common wrapping after surgery to the first postsurgical day and will be provided with compression stockings for the following 10 days, while group B only receives common wrapping and will not be provided with compression stockings.

The investigators are going to investigate the effect of compression stockings on postsurgical swelling and formation of edema on outpatients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are planing on investigate the effect of compression stockings on postsurgical swelling and formation of edema. For this purpose the investigators devide outpatients who have undergone knee surgery to two different clinical study groups. Group A receives a common compression bandage after surgery to the first postsurgical day and receives compression stockings afterwards for the following 10 days, while Group B only receives a common compression bandage to the first postsurgical day. Group A will be instructed to wear compression stockings for 24 hours on the first two postsurgical day, afterwards at least for 8 hours a day.

Preoperatively the investigators are going to determine the volume and circumference of both legs using the Bodytronic 600 by Bauerfeind. Subsequently the measurement will be repeated on the first, forth and tenth postsurgical day. The investigators are going to measure the range of motion, also the patients of both groups will be asked to mark pain and tension on a visual analog scale and write down the amount of time they have been lying, sitting and standing each day. Group A will document the amount of time for how long they were wearing compression stockings each day.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Meckenburg-Vorpommern
      • Rostock, Meckenburg-Vorpommern, Germany, 18057
        • Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 18 years
  • signed release form

Exclusion Criteria:

  • deep vein thrombosis
  • swelling caused by cardiac, venous or endocrine genesis
  • dysfunction of the lymphatic system
  • dysfunction of kidney or liver
  • Use of water withholding medication
  • massive adiposity
  • cachexia
  • epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: B - No compression stockings
normal therapy - no compression stockings
Other: normal therapy - no compression stockings
the patients receive the common therapy according to S2 guidelines
ACTIVE_COMPARATOR: A - Use of compression stockings
Patients use compression stockings for 10 days after surgery
Other: Patients use compression stockings for 10 days after surgery
patients wear compression stocking for 24 hours in the first 2 days after surgery and for at least 8 hours at day 3-10 after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of Swelling of lower Extremity (circumference in mm and volume in ml)
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain (visual analoge scale) and Range of Movement (degree of flexion)
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Investigators

  • Study Director: Thomas Tischer, Prof. Dr., OUK Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

March 23, 2014

First Posted (ESTIMATE)

March 26, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A 2013-0083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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