Swelling Management After Knee Replacement

NCT06095401 | Recruiting

• 2 other identifiers: 23-1142R21AR082101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

swelling

Outcome Measures

Primary Outcomes (1)

• Swelling (bioelectrical impedance)

  Testing will be performed with a RJL Systems Quantum (Clinton Township, MI) bioelectrical impedance device, which delivers a 2.5 uA alternating current at a frequency of 50kHz. Testing will be performed with a four-wire measurement method, consisting of two current-injecting electrodes represented by the red leads (below) and two measuring electrodes (black leads) that detect the voltage drop across the limb. Fours surface electrodes will then be systematically placed on the lower extremity along the second ray on the dorsal surface of the foot separated by 10 cm and at 10 and 20 cm proximal to the superior pole of the patella on the anterior surface of the thigh. Lower levels of impedance represent the increased fluid content present with greater levels of swelling. Measuring the impedance of both the involved and uninvolved limb allows for calculation of ratio (involved/uninvolved).

  Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.

Secondary Outcomes (6)

• Quadriceps strength and activation testing

  Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 3 (primary endpoint) and 12.

• Range of motion

  Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.

• 30-second Sit to Stand test (30-STS)

  Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.

• Numeric pain rating scale

  Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.

• Timed Up and Go test (TUG)

  Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12.

Other Outcomes (2)

• Satisfaction Survey

  Postoperative week 3 (end of intervention - Primary endpoint)

• Adverse Events

  Postoperative weeks 1,2,3 and 12.

Study Arms (2)

Inelastic adjustable compression garment (INCOM)

EXPERIMENTAL

Subjects randomized to the INCOM group will have a CircAid Juxtafit upper leg and knee garment combined with a lower leg garment (Medi USA, Whitsett, NC) applied to their limb at a minimum of 30mm Hg utilizing a standardized garment tensioning tool. The experimental group will be instructed to wear their garments during all waking hours with a target wear time of \>80% of waking hours for the first three weeks after surgery.

Other: Inelastic adjustable compression garment (INCOM)

Elastic compression garment (CONTROL)

ACTIVE COMPARATOR

Subjects randomized to the CONTROL group will have a thigh-length elastic compression garment (thromboembolism-deterrent \[TED\] hose) applied to their limb. The control group will be instructed to wear their garments during all waking hours with a target wear time of \>80% waking hours for the first three weeks after surgery.

Other: Elastic compression garment (CONTROL)

Interventions

Inelastic adjustable compression garment (INCOM) OTHER

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

Inelastic adjustable compression garment (INCOM)

Elastic compression garment (CONTROL) OTHER

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

Elastic compression garment (CONTROL)

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary, unilateral total knee arthroplasty (TKA)
• Age 50 years or older

You may not qualify if:

• Surgical complication necessitating an altered course of rehabilitation
• Unable to attend outpatient rehabilitation 2x/week for 3 weeks following surgery
• Inability to don/doff garment
• Neurological, cardiovascular, or unstable orthopedic conditions that limit function
• Medical conditions that cause chronic lower extremity swelling
• Contralateral TKA within past year
• Pain \>5/10 in their contralateral knee or definite plans on having their other knee replaced in the next year
• Current tobacco smoker
• Use of illegal drugs
• Uncontrolled diabetes (hemoglobin A1c level \>8.0)
• Body mass index \>40 kg/m2

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Colorado Joint Replacement

Denver, Colorado, 80210, United States

RECRUITING

Study Officials

• Michael Bade, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Bade, PhD

CONTACT

303-724-9590; michael.bade@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 23, 2023
• Study Start: February 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Publications will be made available to the public through PubMed Central within one year after the date of publication.

Locations

US (2)