Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490409
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Linda Mie Christensen, Naestved Hospital

Brief Summary:

The number of severely obese patients who has knee replacement surgery is rising. Obesity increases the risk of the postoperative swelling. A complication which can cause pain and discomfort as well as complicate and prolong rehabilitation.

The aim of the present pilot study is to examine the effect of a compression stocking on postoperative swelling and pain among patients with a BMI ≥30 kg/m2, after total knee arthroplasty. The hypothesis is that the use of a medical elastic compression stocking for 14 days postoperatively may reduce postoperative swelling by two cm.

The pilot study will furthermore provide useful information for feasibility which will be used to decide whether or not a larger study should be initiated.


Condition or disease Intervention/treatment Phase
Edema Device: Thigh compression stocking Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Compression Therapy on Postoperative Swelling and Pain, Among Patients With a BMI ≥30 kg/m2, After Total Knee Arthroplasty: A Randomized Controlled Pilot Study
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: compression stocking
The intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery.
Device: Thigh compression stocking
Thigh compression stocking

No Intervention: Conventional treatment
The control group will receive conventional treatment, a compression bandage placed at the end of surgery and removed on the night of the surgery.



Primary Outcome Measures :
  1. Swelling of the knee after operation [ Time Frame: Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery ]
    Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.


Secondary Outcome Measures :
  1. Swelling of the calf after the operation. [ Time Frame: Assessment of swelling of the calf from baseline and 1, 2, 14 days after surgery ]
    Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.

  2. Swelling of the ankle after the operation. [ Time Frame: Assessment of the swelling of the ankle from baseline and 1, 2, 14 days after surgery ]
    Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.

  3. Pain after the operation. [ Time Frame: Assessment of pain from baseline and 1, 2, 14 days after surgery ]
    Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery using Visual Analogue Scale. A pain measurement scale. Minimum score is 0 and maximum score is 100. Higher values represent a worse outcome. Lower values represents a better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned for total knee arthroplasty
  • BMI ≥30 kg/m2, aged 18 or older
  • Speaks, reads and understands Danish
  • Written informed consent.

Exclusion Criteria:

  • Peripheral Arterial Disease
  • Arterial insufficiency
  • No palpable puls at the arteria dorsalis pedis
  • Severe atherosclerosis
  • Leg ulcers
  • Skin disease
  • Fragile "tissue paper" skin
  • Neuropathy or other cause of sensory impairment
  • Allergy to the stocking material
  • Massive leg edema or pulmonary edema from congestive cardiac failure,
  • Deformity of the leg or unusual leg shape or size preventing correct fit
  • Patient that cannot cooperate. For example does not understand the concept of Visual Analogue Scale (VAS) or is not able to use the compression stocking
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490409


Locations
Layout table for location information
Denmark
Department for planned Orthopaedic Surgery
Naestved, Denmark, 4700
Sponsors and Collaborators
Naestved Hospital
Investigators
Layout table for investigator information
Principal Investigator: Linda Mie Christensen, nurse Naestved Sygehus

Layout table for additonal information
Responsible Party: Linda Mie Christensen, Nurse, Naestved Hospital
ClinicalTrials.gov Identifier: NCT03490409    
Other Study ID Numbers: SJ-635
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Mie Christensen, Naestved Hospital:
Arthroplasty
Replacement
Knee
Compression
Edema
Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Edema
Signs and Symptoms