Swelling Management After Total Knee Arthroplasty

July 19, 2022 updated by: University of Colorado, Denver
The purpose of this feasibility study is to estimate the initial efficacy and feasibility of an inelastic compression garment donned immediately after TKA on peak swelling in 14 subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is the most commonly performed surgical procedure in older adults and is expected to increase five-fold by 2040 to 3.5 million TKAs annually. Although TKA is effective at reducing pain and improving self-reported quality of life, postoperative knee swelling after TKA is profound with the average level of swelling peaking at a 35% increase in the first 6-8 days after surgery and persisting months after surgery. Postoperative swelling is associated with a 60% decrease in quadriceps strength in the first month after surgery leading to decreases in functional performance of up to 90%. Patients can exhibit chronic strength deficits on the order of 28-42% based on comparisons with age-matched controls years after surgery. Quadriceps weakness results in long-term decreases in gait speed, balance, stair-climbing ability, chair rise ability, increased risk for falls and disability later in life. Additionally, postoperative knee swelling has also been associated with increased pain, decreased range of motion (ROM) and post-surgical complications such as deep venous thrombosis (DVT) and infection. Traditional postoperative interventions such as elastic compression stockings (e.g., thromboembolism-deterrent (TED) hose) have demonstrated minimal effectiveness in reducing swelling after TKA. We have demonstrated in a preliminary study (N=16) that an inelastic, adjustable compression garment, commonly utilized to manage patients with chronic lymphedema, can decrease postoperative cumulative swelling by 50% in the early postoperative period. With this data, the garment was not applied until postoperative day 4 and thus it had minimal effect on the peak swelling noted after surgery. Peak swelling, not cumulative, is associated with strength and function after TKA. Therefore, this feasibility study aims to mitigate peak swelling by donning the compression garment immediately after surgery in the operating room. It also seeks to assess the feasibility of the intervention from the subjects' perspective.

Specific Aim 1:

Estimate the effect of immediate compression garment (ICG) on the primary outcome of swelling at 4 days and 1, 2, 3, and 6 weeks postoperative.

Hypothesis: The ICG group will have less swelling at 4 days and 1, 2, 3, and 6 weeks postoperative compared to historical controls.

Specific Aim 2:

Determine the participant feasibility of ICG by assessing 1) satisfaction and 2) adherence.

Hypothesis 3.1: Study participants will indicate acceptability of compression garment wear with a median score of at least 4/5 ("somewhat satisfied") on a 5-point Likert scale satisfaction survey.

Hypothesis 3.2: An 80% adherence rate will be observed for compression garment wear as assessed by a patient log.

Study Type

Interventional

Enrollment (Actual)

21

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Joint Replacement

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

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled to undergo a primary, unilateral total knee arthroplasty secondary to end-stage osteoarthritis

Exclusion Criteria:

  • Discharge to location other than home after surgery
  • History of heart failure, lymphatic insufficiency, hepatic disease, pre-existing pitting edema, varicose vein ligation or any other condition associated with lower extremity swelling
  • Unstable orthopedic conditions (besides OA/TKA) that limit function
  • Other neurological, vascular, or cardiac problems that limit function or cause chronic lower extremity swelling
  • No caregiver or inability to touch toes which can affect the ability to don/doff the compression garment
  • Current smoker or history of substance abuse
  • Surgical complication necessitating an altered course of rehabilitation
  • Uncontrolled diabetes (hemoglobin A1c level >8.0)
  • Body mass index >40 kg/m2

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG
Immediate Compression Garment
Procedure: Immediate Compression Garment

Immediately following surgery, in the operating room, the compression garment will be donned on the surgical limb. The garment is set to the following pressures to facilitate gradient compression: 40mm Hg (lower leg), 30mm Hg (knee), 20 mm Hg (thigh) utilizing a standardized garment tensioning tool. Subjects will wear the garment during all waking hours (target wear time of 12 hours daily) for the first 3 weeks after surgery. Additionally, subjects will be instructed to perform a therapeutic exercise program designed to manage swelling by targeting major lower extremity musculature (gastrocnemius, soleus, quadriceps, hamstrings, and gluteal musculature) and promoting venous and lymphatic return. These exercises will be performed five times daily during the first three weeks after surgery.

Subjects will receive standard of care rehabilitation following surgery as directed and coordinated by the surgeon and participant. This rehabilitation is not part of this research study.

Other Names:
  • compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total limb swelling from baseline to day 4 and weeks 1, 2, 3, and 6 postoperative
Time Frame: preoperatively, day 4 and weeks 1, 2, 3, and 6 postoperatively
Assesses swelling in the lower extremity using single frequency bioelectrical impedance.
preoperatively, day 4 and weeks 1, 2, 3, and 6 postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the intervention as measured by self-report logs
Time Frame: week 3 postoperatively
Adherence will be calculated from 0-100% by taking the total number of days the garment was worn for 12+ hours divided by the total number of possible days. Informs feasibility of intervention.
week 3 postoperatively
Subject satisfaction as measured by a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied"
Time Frame: week 3 postoperatively
Assesses the satisfaction of subjects with the intervention using a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied". Informs feasibility of intervention.
week 3 postoperatively

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

Colorado Joint Replacement
medi

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 (Actual)

April 1, 2021

Primary Completion (Actual)

July 14, 2022

Study Completion (Actual)

July 14, 2022

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1722208-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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