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Swelling Management After Total Knee Arthroplasty

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT04841356
Collaborator
Colorado Joint Replacement (Other), medi (Other)
21
Enrollment
1
Location
1
Arm
15.4
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immediate Compression Garment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Swelling Management After Total Knee Arthroplasty
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Jul 14, 2022
Actual Study Completion Date :
Jul 14, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colorado Joint Replacement Denver Colorado United States 80210

    Sponsors and Collaborators

    • University of Colorado, Denver
    • Colorado Joint Replacement
    • medi

    Investigators

    • Principal Investigator: Jason Jennings, MD, Colorado Joint Replacement

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04841356
    Other Study ID Numbers:
    • 1722208-1
    First Posted:
    Apr 12, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Colorado, Denver
    swelling
    compression

    Study Results

    No Results Posted as of Jul 21, 2022