Knee Swelling Under Use of Compression Stockings After Outpatient Surgery
Prospective Randomized Assessment of Postsurgical Swelling Applying Compression Stockings vs. Conventional Wrapping After Outpatient Surgery
1 other identifier
interventional
27
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 11, 2013
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 24, 2016
May 1, 2016
1.7 years
November 11, 2013
May 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of Swelling of lower Extremity (circumference in mm and volume in ml)
10 days
Secondary Outcomes (1)
Pain (visual analoge scale) and Range of Movement (degree of flexion)
10 days
Study Arms (2)
B - No compression stockings
PLACEBO COMPARATORnormal therapy - no compression stockings
A - Use of compression stockings
ACTIVE COMPARATORPatients use compression stockings for 10 days after surgery
Interventions
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
the patients receive the common therapy according to S2 guidelines
Eligibility Criteria
You may qualify if:
- age \> 18 years
- signed release form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
Rostock, Meckenburg-Vorpommern, 18057, Germany
Related Publications (1)
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.
PMID: 30967135DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Tischer, Prof. Dr.
OUK Rostock
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University of Rostock
Study Record Dates
First Submitted
November 11, 2013
First Posted
March 26, 2014
Study Start
July 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 24, 2016
Record last verified: 2016-05