Swelling Management After Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional

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.
    

Intervention name(s): Immediate Compression Garment
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): compression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: swelling; compression