Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751942
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2021-02-09
Brief Title:
Reparel Knee Sleeve vs TED Hose for Post-op Swelling Pain and Range of Motion After Total Knee Replacement
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Post-operative Comparison Between Standard Gradient Compression Dressing vs Non-Compressive Bioactive Garment on Pain Swelling and Range of Motion Following Total Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective study will evaluate pain swelling ROM as well as narcotic use in post-operative total knee arthroplasty patients using novel Non-Compressive Bioactive Garment NCBG versus current standard of care gradient compression stocking Thrombo-Embolic-Deterrent or TED hose If NCBG proves to be more effective in these outcome areas it will provide a new and comfortable way to reduce patient pain and swelling immediately following surgery
Detailed Description:
Total knee arthroplasty TKA is one of the most popular surgical procedures today It is designed and proven to effectively reduce pain caused by end-stage osteoarthritis Despite its achievements up to 25 of patients remain dissatisfied after the procedure due to lingering pain amongst other complaints Post-operative swelling of the knee and leg is thought to be a contributor to this persistent pain
Traditionally a standard gradient compression stocking is applied to the knee and leg after surgery to reduce this pain and swelling However due to ineffectiveness or patient non-compliance compression stockings are often not entirely successful at preventing edema The recently developed NCPS is a lower extremity garment comprised of a technical fabric that is thought to be able to prevent edema and reduce pain all in a comfortable user-friendly manner The purpose of this study is to determine if the NCPS is effective at improving post-operative pain swelling ROM and analgesic use associated with TKA
Pain and prolonged recovery time associated with post-operative swelling are two factors that contribute to patient dissatisfaction following TKA Swelling of the knee following TKA is caused by intraarticular bleeding and inflammation of the periarticular tissues which can lead to a decrease in functional performance including pain and delayed rehabilitation In a study by Noble et al 13 of dissatisfied patients reported that their knees swelled at least once per week leading to pain and discomfort1 Decreased quadriceps strength following knee surgery has been shown to prolong recovery1-8 Fahrer et al showed that knee effusions inhibited reflex neurons and altered kinetics and muscle activity in quadriceps which ultimately causes decreased strength2 Holm et al later showed us that knee swelling played a part in post-operative quadriceps strength following TKA3 Ultimately if post-operative swelling can effectively be reduced patient recovery could be expedited and patient satisfaction could be improved
Compression stockings have been utilized to attempt to reduce post-operative swelling Compression works to prevent swelling by reducing the hydrostatic pressure in the leg Reducing hydrostatic pressure prevents the capillaries from oozing and allows blood to move freely from the superficial to the deep venous system subsequently allowing excess fluid to flow away from the interstitial space9
More recently the use of gradient compression stocking following TKA has come into question for its efficacy While the application of external pressure from these gradient compression stocking is beneficial for a period they are often unable to exert a sufficient amount of pressure long enough to prevent painful edema for an extended amount of time A study by Bowling et al showed that these garments showed sufficient compression during the first few hours after surgery but the pressure they applied dropped with time and required daily measurements and refitting to maintain appropriate and therapeutic compression10 This poses a problem not only medically but financially as well These compression stockings lose their fit so quickly new ones must be prescribed frequently leading to costly bills for the patient Its clear that compression stockings are not as effective as once thought when it comes to controlling pain and swelling post-operatively
A potential solution to the problems posed by traditional compression stocking is the NCPG The garment is comprised of a semi-conductive material ground to nanoparticles that are embedded into the fibers formed into a three-dimensional woven fabric for optimized comfort Instead of relying on compression NCPS utilizes the bodys own thermal energy to generate infrared energy The infrared energy generated is reflected back at the body and modifies cellular activity at the level of the mitochondria through a process known as photobiomodulation14-15 This process of photobiomodulation is hypothesized to improve swelling and tissue healing by increasing the activity of mitochondria and the availability of cellular energy in the form of ATP
This study seeks to determine if NCPS use of infrared energy is more successful at reducing pain and swelling following TKA than traditional gradient compression dressing
We will enroll 100 subjects throughout all sites involved in the study
Patients will be recruited in the office setting after all non-operative modalities for controlling pain associated with end-stage osteoarthritis of the knee have been exhausted Patients will then be presented with the option of total knee replacement After patient has agreed to undergo TKA patients will then be asked in a face-to-face setting if they would like to participate in the study
Patients will be approached in the office setting after it has been determined that they have failed conservative management of advanced knee arthritis Patients will be in the surgeons clinic behind closed doors with the performing surgeon and potentially other members of the research team Consent will be obtained in the office after scheduling total knee arthroplasty procedure The consent process is expected to take 30 minutes but more time is available to ensure that patients have all their questions answered prior to signing the consent form
Patients will be enrolled in study prior to surgery outlined above in the consent process
On the day of surgery patients will arrive and will be situated in the pre-operative holding area A trained member of the research team will meet the patient in the pre-operative holding area and will measure the circumference of the patients leg at the mid-thigh mid-knee and mid-calf The patients range of motion of the operative leg will be measured in flexion and extension All measurements will be recorded in redcap
The patient will then go on to have their primary total knee arthroplasty by standard of care procedure Both cruciate retaining and posterior stabilized total knee replacement designs will be included in the study Following closure of the surgical site and placement of a post-operative occlusive dressing the operative leg will be measured once more for circumference and range of motion and the values will be entered into redcap The patient will then be placed in their randomized post-operative sleevedevice and will be transferred to the PACU and will receive the standard post-operative treatment
On post-operative day one patients will be seen and evaluated in their inpatient rooms Their leg measurements will be taken again with the knee sleevecompressive gradient dressing pulled down Patients skin will be inspected for any reactions to the sleeve and a standard post-operative examination will be performed to ensure no neurovascular compromise blood clots infections or other post-operative complications
Patients will likely be discharged on post-operative day 1 Patients that have not been discharged on post-operative day 1 will not be measured on post-operative day 2
Patients will be provided with a journal that they will use every daily to track their pain based on a visual analog scale and their narcotic consumption number of Percocet or tramadol pills Patients will also use their journal to log the number of hours they wore their sleeve each day Patients will continue to log the number of pain medications taken and hours wearing the sleeve for 6 weeks
Sleeves will be worn morning and night removing them only for hygiene and washing of sleeve for 2 weeks After 2 weeks the patients will wear the sleeve as much as they can tolerate day and night At 6 weeks sleeves will be discontinued all together Final ROM and Circumference Measurements will be obtained at 12 weeks post-operative mark
Patients will be asked to fill out the Knee Society Score questionnaire at the time of consent and at each post-operative visit
The Reparel leg sleeve is the experimental device being investigated in this study It is intended to improve swelling in the post-operative knee
Allscripts Electronic Medical Records will be used to collect data about patients during their inpatient post-operative stay UH Care ambulatory EMR and Medent EMR will be used in the outpatient setting to collect data and track post-operative clinic visits
The enrollment period will be 1 year from the time of the first patient enrolled in the study The enrollment period may be expanded to allow for the investigators to reach their goal of 100 patients The total amount of time each patient will be involved in the study will be 12 weeks Patients will only be required to wear the post-operative sleevedressing for 6 weeks post-operatively Patients will continue to record their narcotic consumption and pain scores for 12 weeks post-operatively
Date to be collected
Mid-thigh mid-knee and mid-calf measurements ROM measurements in knee flexion and knee extension Visual analog Pain scale Knee society score KSS Narcotic consumption Name Medical record number Surgeon weight
Data Analysis Plan
Demographics will be reported using descriptives such as count data and percentages Differences between groups at baseline pre-op will be reported using two-tailed independent t-tests for continuous variables and chi-square or Fishers Exact tests for categorical data as appropriate
The primary outcomes of range of motion leg circumference and pain ratings will be compared post-op between conditions using two-tailed independent t-tests Should clinically relevant demographics differ significantly between conditions pre-op baseline post-op comparisons will instead be conducted using one-way ANCOVAs controlling for differences at pre-op baseline These comparisons will additionally be made at multiple additional time-points throughout a 12-week post-op time period
A priori power analyses were calculated for two-tailed independent t-tests for each primary outcome using an alpha of 05 power 80 Each of these are reported and the average of these numbers is used to calculate the final sample size Clinically significant reductions in pain are defined as a 2-point change with a standard deviation of 25 using a 10-point scale 84 patients were estimated Clinically significant changes in range of motion are defined as 10 degrees of difference from a 0-140 degree estimated range of values Clinically significant changes in leg circumference are defined as 1 cm difference in leg circumference using a 15-30 estimated range of values To identify medium effect sizes of 55 106 patients were estimated Averaging these values 99 patients were estimated To ensure equal numbers of patients in each condition 100 patients will be recruited for this study
The data will be monitored every 10 patients to assess for completeness accuracy and adherence to the protocol We will also be monitoring for any obvious safety concerns that may arise
There will not be a designated safety team assigned
Traditionally a standard gradient compression stocking is applied to the knee and leg after surgery to reduce this pain and swelling However due to ineffectiveness or patient non-compliance compression stockings are often not entirely successful at preventing edema The recently developed NCPS is a lower extremity garment comprised of a technical fabric that is thought to be able to prevent edema and reduce pain all in a comfortable user-friendly manner The purpose of this study is to determine if the NCPS is effective at improving post-operative pain swelling ROM and analgesic use associated with TKA
Pain and prolonged recovery time associated with post-operative swelling are two factors that contribute to patient dissatisfaction following TKA Swelling of the knee following TKA is caused by intraarticular bleeding and inflammation of the periarticular tissues which can lead to a decrease in functional performance including pain and delayed rehabilitation In a study by Noble et al 13 of dissatisfied patients reported that their knees swelled at least once per week leading to pain and discomfort1 Decreased quadriceps strength following knee surgery has been shown to prolong recovery1-8 Fahrer et al showed that knee effusions inhibited reflex neurons and altered kinetics and muscle activity in quadriceps which ultimately causes decreased strength2 Holm et al later showed us that knee swelling played a part in post-operative quadriceps strength following TKA3 Ultimately if post-operative swelling can effectively be reduced patient recovery could be expedited and patient satisfaction could be improved
Compression stockings have been utilized to attempt to reduce post-operative swelling Compression works to prevent swelling by reducing the hydrostatic pressure in the leg Reducing hydrostatic pressure prevents the capillaries from oozing and allows blood to move freely from the superficial to the deep venous system subsequently allowing excess fluid to flow away from the interstitial space9
More recently the use of gradient compression stocking following TKA has come into question for its efficacy While the application of external pressure from these gradient compression stocking is beneficial for a period they are often unable to exert a sufficient amount of pressure long enough to prevent painful edema for an extended amount of time A study by Bowling et al showed that these garments showed sufficient compression during the first few hours after surgery but the pressure they applied dropped with time and required daily measurements and refitting to maintain appropriate and therapeutic compression10 This poses a problem not only medically but financially as well These compression stockings lose their fit so quickly new ones must be prescribed frequently leading to costly bills for the patient Its clear that compression stockings are not as effective as once thought when it comes to controlling pain and swelling post-operatively
A potential solution to the problems posed by traditional compression stocking is the NCPG The garment is comprised of a semi-conductive material ground to nanoparticles that are embedded into the fibers formed into a three-dimensional woven fabric for optimized comfort Instead of relying on compression NCPS utilizes the bodys own thermal energy to generate infrared energy The infrared energy generated is reflected back at the body and modifies cellular activity at the level of the mitochondria through a process known as photobiomodulation14-15 This process of photobiomodulation is hypothesized to improve swelling and tissue healing by increasing the activity of mitochondria and the availability of cellular energy in the form of ATP
This study seeks to determine if NCPS use of infrared energy is more successful at reducing pain and swelling following TKA than traditional gradient compression dressing
We will enroll 100 subjects throughout all sites involved in the study
Patients will be recruited in the office setting after all non-operative modalities for controlling pain associated with end-stage osteoarthritis of the knee have been exhausted Patients will then be presented with the option of total knee replacement After patient has agreed to undergo TKA patients will then be asked in a face-to-face setting if they would like to participate in the study
Patients will be approached in the office setting after it has been determined that they have failed conservative management of advanced knee arthritis Patients will be in the surgeons clinic behind closed doors with the performing surgeon and potentially other members of the research team Consent will be obtained in the office after scheduling total knee arthroplasty procedure The consent process is expected to take 30 minutes but more time is available to ensure that patients have all their questions answered prior to signing the consent form
Patients will be enrolled in study prior to surgery outlined above in the consent process
On the day of surgery patients will arrive and will be situated in the pre-operative holding area A trained member of the research team will meet the patient in the pre-operative holding area and will measure the circumference of the patients leg at the mid-thigh mid-knee and mid-calf The patients range of motion of the operative leg will be measured in flexion and extension All measurements will be recorded in redcap
The patient will then go on to have their primary total knee arthroplasty by standard of care procedure Both cruciate retaining and posterior stabilized total knee replacement designs will be included in the study Following closure of the surgical site and placement of a post-operative occlusive dressing the operative leg will be measured once more for circumference and range of motion and the values will be entered into redcap The patient will then be placed in their randomized post-operative sleevedevice and will be transferred to the PACU and will receive the standard post-operative treatment
On post-operative day one patients will be seen and evaluated in their inpatient rooms Their leg measurements will be taken again with the knee sleevecompressive gradient dressing pulled down Patients skin will be inspected for any reactions to the sleeve and a standard post-operative examination will be performed to ensure no neurovascular compromise blood clots infections or other post-operative complications
Patients will likely be discharged on post-operative day 1 Patients that have not been discharged on post-operative day 1 will not be measured on post-operative day 2
Patients will be provided with a journal that they will use every daily to track their pain based on a visual analog scale and their narcotic consumption number of Percocet or tramadol pills Patients will also use their journal to log the number of hours they wore their sleeve each day Patients will continue to log the number of pain medications taken and hours wearing the sleeve for 6 weeks
Sleeves will be worn morning and night removing them only for hygiene and washing of sleeve for 2 weeks After 2 weeks the patients will wear the sleeve as much as they can tolerate day and night At 6 weeks sleeves will be discontinued all together Final ROM and Circumference Measurements will be obtained at 12 weeks post-operative mark
Patients will be asked to fill out the Knee Society Score questionnaire at the time of consent and at each post-operative visit
The Reparel leg sleeve is the experimental device being investigated in this study It is intended to improve swelling in the post-operative knee
Allscripts Electronic Medical Records will be used to collect data about patients during their inpatient post-operative stay UH Care ambulatory EMR and Medent EMR will be used in the outpatient setting to collect data and track post-operative clinic visits
The enrollment period will be 1 year from the time of the first patient enrolled in the study The enrollment period may be expanded to allow for the investigators to reach their goal of 100 patients The total amount of time each patient will be involved in the study will be 12 weeks Patients will only be required to wear the post-operative sleevedressing for 6 weeks post-operatively Patients will continue to record their narcotic consumption and pain scores for 12 weeks post-operatively
Date to be collected
Mid-thigh mid-knee and mid-calf measurements ROM measurements in knee flexion and knee extension Visual analog Pain scale Knee society score KSS Narcotic consumption Name Medical record number Surgeon weight
Data Analysis Plan
Demographics will be reported using descriptives such as count data and percentages Differences between groups at baseline pre-op will be reported using two-tailed independent t-tests for continuous variables and chi-square or Fishers Exact tests for categorical data as appropriate
The primary outcomes of range of motion leg circumference and pain ratings will be compared post-op between conditions using two-tailed independent t-tests Should clinically relevant demographics differ significantly between conditions pre-op baseline post-op comparisons will instead be conducted using one-way ANCOVAs controlling for differences at pre-op baseline These comparisons will additionally be made at multiple additional time-points throughout a 12-week post-op time period
A priori power analyses were calculated for two-tailed independent t-tests for each primary outcome using an alpha of 05 power 80 Each of these are reported and the average of these numbers is used to calculate the final sample size Clinically significant reductions in pain are defined as a 2-point change with a standard deviation of 25 using a 10-point scale 84 patients were estimated Clinically significant changes in range of motion are defined as 10 degrees of difference from a 0-140 degree estimated range of values Clinically significant changes in leg circumference are defined as 1 cm difference in leg circumference using a 15-30 estimated range of values To identify medium effect sizes of 55 106 patients were estimated Averaging these values 99 patients were estimated To ensure equal numbers of patients in each condition 100 patients will be recruited for this study
The data will be monitored every 10 patients to assess for completeness accuracy and adherence to the protocol We will also be monitoring for any obvious safety concerns that may arise
There will not be a designated safety team assigned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None