Swelling Management After Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Procedure: Immediate Compression Garment

• Registration Number: NCT04841356
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-12
• Status Verified: 2022-07
• Primary Completion: 2022-07-14
• Study Completion: 2022-07-14
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG	Immediate Compression Garment	Immediate Compression Garment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adherence to the intervention as measured by self-report logs	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.
Subject satisfaction as measured by a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied"	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.

Trial Locations

Locations (1)

Colorado Joint Replacement; 🇺🇸 Denver, Colorado, United States