Knee Swelling Under Use of Compression Stockings After Outpatient Surgery

NCT ID: NCT02096562

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Pain Swelling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B - No compression stockings

normal therapy - no compression stockings

Group Type PLACEBO_COMPARATOR

normal therapy - no compression stockings

Intervention Type OTHER

the patients receive the common therapy according to S2 guidelines

A - Use of compression stockings

Patients use compression stockings for 10 days after surgery

Group Type ACTIVE_COMPARATOR

Patients use compression stockings for 10 days after surgery

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

normal therapy - no compression stockings

the patients receive the common therapy according to S2 guidelines

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Oye

University of Rostock

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Tischer, Prof. Dr.

Role: STUDY_DIRECTOR

OUK Rostock

Locations

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Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock

Rostock, Meckenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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Tischer TS, Oye S, Lenz R, Kreuz P, Mittelmeier W, Bader R, Tischer T. Impact of compression stockings on leg swelling after arthroscopy - a prospective randomised pilot study. BMC Musculoskelet Disord. 2019 Apr 9;20(1):161. doi: 10.1186/s12891-019-2540-1.

Reference Type DERIVED
PMID: 30967135 (View on PubMed)

Other Identifiers

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A 2013-0083

Identifier Type: -

Identifier Source: org_study_id

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