Arthroplasties, Knee ReplacementNCT06095401
Swelling Management After Knee Replacement
A study testing Inelastic adjustable compression garment (INCOM) in people with Arthroplasties, Knee Replacement, run by University of Colorado, Denver at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasties, Knee Replacement
- What is being tested?
- Inelastic adjustable compression garment (INCOM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary, unilateral total knee arthroplasty (TKA)
- Age 50 years or older
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Michael Bade, PhD, DPT, 303-724-9025, michael.bade@cuanschutz.edu
- Recruiting
Colorado Joint Replacement
Denver, Colorado, 80210
Roseann Johnson, BS, 303-260-2940, roseann.johnson@adventhealth.com
About this study
Official title: Swelling Management After Total Knee Arthroplasty: A Randomized Controlled Trial
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).
Read the 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
- Being tested
- Inelastic adjustable compression garment (INCOM), Elastic compression garment (CONTROL)
- Keywords
- swelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Elastic compression garment (CONTROL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Maximum voluntary isometric quadriceps strength of the surgical and non-surgical limb will be assessed using an electromechanical dynamometer (Humac Norm, CSMI). Testing will be repeated up to 3 times with 1 minute of rest between trials, until 2 attempts are within 5% of each other. The trial with the largest maximal volitional isometric force output will then be normalized to each participant's body weight (in kilograms) and used for data analysis. Voluntary activation of the quadriceps muscle will be assessed using the doublet interpolation technique, where a supramaximal stimulus will be applied during an MVIC and again, immediately afterward, with the quadriceps muscle is at rest.
Measured: 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
Knee ROM will be measured actively in the supine position actively using a long-arm goniometer.
Measured: 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)
The 30 second sit to stand test measures the number of times a subject can rise from a seated position without the use of hands.
Measured: 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
Pain will be assessed using a verbal numeric pain rating scale (NPRS) from 0 to 10 where 0 represents "no pain" and 10 represents the "worst imaginable pain." The NPRS will be assessed at baseline, after each MVIC during strength testing, and after each functional performance measure
Measured: 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)
The Timed up and go test measures the amount of time it takes for an individual to rise from a chair, walk 3m, turn around, walk back to the chair, and return to a seated position.
Measured: 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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. The WOMAC measures three separate dimensions: 1) Pain (5 questions); 2) Stiffness (2 questions); 3) Function (17 questions).
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start21 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasties, Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Michael Bade, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095401
- Sponsor's protocol ID
- 23-1142
- Other IDs
- R21AR082101
- Status last verified
- May 2024
- First submitted
- 2 Oct 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be shared in a publication, which will be available through PubMed within a year of publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swelling Management After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06095401
- Acronym / sponsor ID
- 23-1142
- Conditions
- Arthroplasties, Knee Replacement
- Keywords
- swelling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inelastic adjustable compression garment (INCOM) | Experimental | Other: 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. |
| Elastic compression garment (CONTROL) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary, unilateral total knee arthroplasty (TKA)
- Age 50 years or older
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Inelastic adjustable compression garment (INCOM) |
| 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 | Other | Elastic compression garment (CONTROL) |
Primary outcome
Swelling (bioelectrical impedance)
Time frame: 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.
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).
6 secondary outcomes
Quadriceps strength and activation testing
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be shared in a publication, which will be available through PubMed within a year of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bade, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inelastic adjustable compression garment (INCOM) in people with Arthroplasties, Knee Replacement, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Bade, PhD (303-724-9590, michael.bade@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swelling (bioelectrical impedance) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.