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Swelling Management After Total Knee Arthroplasty

NCT04841356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-07-21

No results posted yet for this study

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.

Conditions

  • Total Knee Arthroplasty

Interventions

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.

Sponsors & Collaborators

  • Colorado Joint Replacement

    collaborator OTHER

  • medi

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jason Jennings, MD · Colorado Joint Replacement

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-07-14
Completion
2022-07-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841356 on ClinicalTrials.gov