Knee Swelling Under Use of Compression Stockings After Outpatient Surgery

Knee Pain Swelling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096562
• Other study ID #: A 2013-0083
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: May 23, 2016
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Knee Pain Swelling

Intervention

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
• normal therapy - no compression stockings
the patients receive the common therapy according to S2 guidelines

Locations

Country	Name	City	State
Germany	Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock	Rostock	Meckenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Swelling of lower Extremity (circumference in mm and volume in ml)		10 days	No
Secondary	Pain (visual analoge scale) and Range of Movement (degree of flexion)		10 days	No