Trial Outcomes & Findings for Reparel Knee Sleeve vs. TED Hose for Post-op Swelling, Pain and Range of Motion After Total Knee Replacement (NCT NCT04751942)
NCT ID: NCT04751942
Last Updated: 2025-11-04
Results Overview
the narcotic consumption in Milligrams of morphine equivalents (MME) per day will be recorded post-operatively while in the hospital and will be self reported by the patient in a journal as "number of pills" taken
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
1 week Post-op, 2 weeks Post-op. 6 weeks Post-op, 3 months Post-op
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Thrombo-Embolic Deterrent
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
Non-compressive Bioactive Garment
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
14
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Thrombo-Embolic Deterrent
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
Non-compressive Bioactive Garment
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
Baseline Characteristics
Reparel Knee Sleeve vs. TED Hose for Post-op Swelling, Pain and Range of Motion After Total Knee Replacement
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Preop, 2 weeks post op, 6 weeks post-op, 3 months post-opPopulation: Data was collected for participants that showed at each follow up apt, some did not come to all follow up apts.
circumference of the leg will be measured pre-operatively, immediately post operatively, and at regular intervals post-operatively.
Outcome measures
| Measure |
Non-compressive Bioactive Garment
n=13 Participants
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
Thrombo-Embolic Deterrent
n=8 Participants
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
|---|---|---|
|
Change in Leg Circumference (cm)
3 months Post-op
|
46.36 Leg circumference (cm)
Standard Deviation 5.65
|
45.89 Leg circumference (cm)
Standard Deviation 1.87
|
|
Change in Leg Circumference (cm)
6 weeks Post-op
|
45.17 Leg circumference (cm)
Standard Deviation 5.85
|
46.14 Leg circumference (cm)
Standard Deviation 2.16
|
|
Change in Leg Circumference (cm)
Pre-op
|
44.06 Leg circumference (cm)
Standard Deviation 3.77
|
44.77 Leg circumference (cm)
Standard Deviation 6.34
|
|
Change in Leg Circumference (cm)
2 weeks Post-op
|
44.18 Leg circumference (cm)
Standard Deviation 4.25
|
49.99 Leg circumference (cm)
Standard Deviation 5.19
|
PRIMARY outcome
Timeframe: Pre-op, 1 week Post-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-opPopulation: Data was collected for participants that showed at each follow up apt, some did not come to all follow up apts.
patient's subjective pain scores will be recorded daily in a pain journal using a visual analog scale from 1-10, values are grouped into mild (1-3), moderate (4-6), and severe (7-10) pain.
Outcome measures
| Measure |
Non-compressive Bioactive Garment
n=14 Participants
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
Thrombo-Embolic Deterrent
n=9 Participants
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
|---|---|---|
|
Change in Pain Score (1-10)
2 weeks Post-op
|
2.92 score on a scale
Standard Deviation 1.5
|
4.25 score on a scale
Standard Deviation 2.44
|
|
Change in Pain Score (1-10)
6 weeks Post-op
|
1.25 score on a scale
Standard Deviation 0.97
|
2 score on a scale
Standard Deviation 0.82
|
|
Change in Pain Score (1-10)
3 months Post-op
|
1.4 score on a scale
Standard Deviation 0.8
|
1.33 score on a scale
Standard Deviation 0.47
|
|
Change in Pain Score (1-10)
Pre-op
|
4.07 score on a scale
Standard Deviation 1.8
|
4.44 score on a scale
Standard Deviation 1.64
|
|
Change in Pain Score (1-10)
1 week Post-op
|
3.67 score on a scale
Standard Deviation 1.25
|
4 score on a scale
Standard Deviation 1.67
|
PRIMARY outcome
Timeframe: Pre-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-opPopulation: Data was collected for participants that showed at each follow up apt, some did not come to all follow up apts.
patients passive flexion range of motion will be tested pre-operatively, immediately post-operatively, and at regular intervals post-operatively
Outcome measures
| Measure |
Non-compressive Bioactive Garment
n=13 Participants
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
Thrombo-Embolic Deterrent
n=8 Participants
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
|---|---|---|
|
Change in Range of Motion
Pre-op
|
121.85 Degrees
Standard Deviation 13.81
|
116.88 Degrees
Standard Deviation 25.61
|
|
Change in Range of Motion
2 weeks Post-op
|
99.08 Degrees
Standard Deviation 13.16
|
95.29 Degrees
Standard Deviation 15.46
|
|
Change in Range of Motion
6 weeks Post-op
|
117.13 Degrees
Standard Deviation 15.91
|
114 Degrees
Standard Deviation 13.59
|
|
Change in Range of Motion
3 months Post-op
|
113.4 Degrees
Standard Deviation 5.12
|
115.33 Degrees
Standard Deviation 7.76
|
PRIMARY outcome
Timeframe: 1 week Post-op, 2 weeks Post-op. 6 weeks Post-op, 3 months Post-opPopulation: Data was collected for participants that showed at each follow up apt, some did not come to all follow up apts.
the narcotic consumption in Milligrams of morphine equivalents (MME) per day will be recorded post-operatively while in the hospital and will be self reported by the patient in a journal as "number of pills" taken
Outcome measures
| Measure |
Non-compressive Bioactive Garment
n=12 Participants
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
Thrombo-Embolic Deterrent
n=8 Participants
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
|---|---|---|
|
Change in Narcotic Consumption
1 week Post-op
|
1.56 Milligrams of morphine equivalents.day
Standard Deviation 1.42
|
2 Milligrams of morphine equivalents.day
Standard Deviation 1.79
|
|
Change in Narcotic Consumption
2 week Post-op
|
1.58 Milligrams of morphine equivalents.day
Standard Deviation 1.26
|
2.5 Milligrams of morphine equivalents.day
Standard Deviation 2.35
|
|
Change in Narcotic Consumption
6 weeks Post-op
|
0.25 Milligrams of morphine equivalents.day
Standard Deviation 0.43
|
0 Milligrams of morphine equivalents.day
Standard Deviation 0
|
|
Change in Narcotic Consumption
3 months Post-op
|
0 Milligrams of morphine equivalents.day
Standard Deviation 0
|
0 Milligrams of morphine equivalents.day
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Pre-op, 1 week Post-op, 2 weeks Post-op, 6 weeks Post-op, 3 months Post-opPopulation: Data was collected for participants that showed at each follow up apt, some did not come to all follow up apts.
a validated system that combines an objective physician-derived component with a subjective patient-derived component that evaluates pain relief, functional abilities, satisfaction, and fulfillment of expectations. Patients will fill out this questionnaire pre-operatively and at each post-operative visit. With lower scores indicating lower pain/difficulty with daily activities and higher scores indicating higher pain/difficulty with daily activities.
Outcome measures
| Measure |
Non-compressive Bioactive Garment
n=14 Participants
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
Thrombo-Embolic Deterrent
n=9 Participants
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
|---|---|---|
|
Change in Knee Society Score (KSS)
Pre-op
|
38.29 units on a scale
Standard Deviation 16.25
|
40.33 units on a scale
Standard Deviation 13.81
|
|
Change in Knee Society Score (KSS)
1 week Post-op
|
33.33 units on a scale
Standard Deviation 14.45
|
33 units on a scale
Standard Deviation 16.90
|
|
Change in Knee Society Score (KSS)
2 weeks Post-op
|
23.92 units on a scale
Standard Deviation 14.30
|
31.25 units on a scale
Standard Deviation 23.68
|
|
Change in Knee Society Score (KSS)
6 weeks Post-op
|
10.63 units on a scale
Standard Deviation 8.01
|
15.67 units on a scale
Standard Deviation 4.78
|
|
Change in Knee Society Score (KSS)
3 months Post-op
|
11.2 units on a scale
Standard Deviation 7.96
|
22.67 units on a scale
Standard Deviation 23.57
|
Adverse Events
Non-compressive Bioactive Garment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thrombo-Embolic Deterrent
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-compressive Bioactive Garment
n=14 participants at risk
The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
Non-compressive Bioactive Garment: patients will be assigned to wear the non-compressive bioactive garment following total knee arthroplasty
|
Thrombo-Embolic Deterrent
n=9 participants at risk
a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.
thrombo-embolic deterrent: patients will be randomized to wear the gold standard TED hose following total knee arthroplasty
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Surgical site infection
|
0.00%
0/14 • Up to 3 months post-op
|
22.2%
2/9 • Number of events 2 • Up to 3 months post-op
|
Other adverse events
Adverse event data not reported
Additional Information
Rachael Kilkenny
Univeristy Hosptials Cleveland Medical Center
Phone: 216-545-4850
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place