Study Results
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Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2024-02-21
2026-04-30
Brief Summary
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Detailed Description
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Knee swelling after TKA is profound and is theorized to be a major driver of this acute strength and functional loss. The average level of swelling peaks at a 35% increase in the first week after surgery. During the initial postoperative period, quadriceps strength decreases by 60% leading to decreases in functional performance of up to 90%. This early postoperative strength loss is driven by a deficit in quadriceps activation which limits rehabilitation potential acutely and leads to long term losses of quadriceps strength up to 42%. Quadriceps weakness results in long-term decreases in gait speed, balance, stair-climbing ability, and chair rise ability. Early functional decline increases the risk for falls and disability later in life. Furthermore, 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. However, traditional postoperative interventions such as elastic compression stockings (thromboembolism-deterrent \[TED\] hose) have demonstrated minimal effectiveness in reducing swelling after TKA.
The investigators have demonstrated in a pilot cohort study (N=16) that an inelastic, adjustable compression garment was related to decreases in swelling by 50% in the early postoperative period. However, there is a need to more formally evaluate the effects of this garment in a more robust design as well as determine the preliminary effects of this garment on important downstream clinical outcomes (e.g., strength and function) prior to initiating a larger clinical trial.
Therefore, the investigators propose a randomized controlled study of 58 older adult participants undergoing TKA to determine if the utilization of an inelastic adjustable compression garment (INCOM) reduces postoperative swelling more than elastic TED hose (CONTROL). Both groups will wear the assigned garments for the first three weeks after TKA and participate in a standardized rehabilitation program after TKA. Outcomes will be assessed preoperatively and postoperatively at weeks 1,2, 3 (end of intervention), and 12.
AIM 1: To determine if INCOM results in improved surgical limb swelling control (bioimpedance assessment - primary outcome) after TKA compared to CONTROL.
Hypothesis 1: INCOM will demonstrate reduced surgical limb swelling compared to the CONTROL group at 1, 2, and 3 weeks (primary endpoint) after TKA, and group differences will persist at 12 weeks.
AIM 2: To explore the preliminary efficacy of INCOM on the outcomes of quadriceps strength (dynamometer), pain (numeric pain rating scale), ROM (goniometry), physical function (30-second Sit to Stand test, Timed Up and Go), and patient-reported outcomes (WOMAC) compared to CONTROL.
Hypothesis 2: Direction of the effect will favor the INCOM group for strength, pain, ROM, physical function, and patient-reported outcomes compared to the CONTROL group at weeks 1,2, 3 and 12 weeks after TKA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inelastic adjustable compression garment (INCOM)
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.
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
Elastic compression garment (CONTROL)
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.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Age 50 years or older
Exclusion Criteria
* 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
50 Years
120 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Michael Bade, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Colorado Joint Replacement
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-1142
Identifier Type: -
Identifier Source: org_study_id
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