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Swelling Management After Knee Replacement

NCT06095401 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-05-23

No results posted yet for this study

Summary

To determine if inelastic adjustable compression garment results in improved surgical limb swelling control (bioimpedance assessment - primary outcome) after TKA compared to control (TED hose).

Conditions

  • Arthroplasties, Knee Replacement

Interventions

OTHER

Inelastic adjustable compression garment (INCOM)

Immediately following surgery, participants randomized to INCOM will wear an inelastic adjustable compression garment set to a minimum of 30mm Hg of compression utilizing a standardized garment tensioning tool. Participants will be instructed to wear the compression garment during waking hours with a target wear time of 80% of waking hours. Participants will participate in a standardized rehabilitation program

OTHER

Elastic compression garment (CONTROL)

Immediately following surgery, participants randomized to CONTROL will wear a thigh-length elastic compression garment (thromboembolism-deterrent \[TED\] hose) for the first 3 weeks after TKA. Participants will be instructed to wear the compression garment during waking hours with a target wear time of 80% of waking hours. Participants will participate in a standardized rehabilitation program

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Michael Bade, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2025-12-31
Completion
2026-04-30

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 NCT06095401 on ClinicalTrials.gov