NCT06095401

Swelling Management After Knee Replacement

Swelling Management After Total Knee Arthroplasty: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 50 Years – 120 Years
• Healthy volunteers: Accepted

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).

Detailed description

Total knee arthroplasty (TKA) is commonly performed to address disability from end-stage osteoarthritis (OA) 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, it is a substantial acute trauma to the joint that exacerbates the underlying weakness and disability common with OA, leading to long-term atrophy and further disability. Attenuation of this acute loss of strength and function leads to improved long-term outcomes. Key to preventing this acute loss is effectively managing postoperative knee swelling. 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

• Arthroplasties, Knee Replacement

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-21
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2023-10-23
• Last updated: 2024-05-23

Locations

2 sites across 1 country: United States