Trial Outcomes & Findings for Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery (NCT NCT00711711)
NCT ID: NCT00711711
Last Updated: 2019-01-18
Results Overview
The bioimpedance, i.e. a measurement in ohms of the opposition to current flow between electrodes was evaluated for each limb. Then the bioimpedance percentage difference between operated and healthy limb was calculated.
COMPLETED
NA
60 participants
presurgery, 2 days, 7 days and 3 months post surgery
2019-01-18
Participant Flow
Patients from the Department of Orthopedic and Traumatic Surgery of the University Hospital of Lausanne were recruited from July 1, 2008 to November 16, 2010
Participant milestones
| Measure |
Manual Lymphatic Drainage
This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery
Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery
|
Relaxation
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery
Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
Second Postsurgical Day
|
30
|
30
|
|
Overall Study
Seventh Postsurgical Day
|
29
|
27
|
|
Overall Study
COMPLETED
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery
Baseline characteristics by cohort
| Measure |
Manual Lymphatic Drainage
n=30 Participants
This arm will receive 5 manual lymphatic drainage treatments from day 2 to day 7 post surgery
Manual lymphatic drainage: Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery
|
Relaxation
n=30 Participants
This arm will receive 5 relaxation treatments from day 2 to day 7 post surgery
Relaxation: Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
70.1 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
70.7 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: presurgery, 2 days, 7 days and 3 months post surgeryPopulation: At day 7, 3 patients lost at follow up in the control group and 1 in the treatment group. At 3 months, 3 more patients lost at follow up in the control group.
The bioimpedance, i.e. a measurement in ohms of the opposition to current flow between electrodes was evaluated for each limb. Then the bioimpedance percentage difference between operated and healthy limb was calculated.
Outcome measures
| Measure |
Placebo
n=30 Participants
Patients who received relaxation as placebo intervention
|
Manual Lymphatic Drainage
n=30 Participants
Patients who received manual lymphatic drainage as the study intervention
|
|---|---|---|
|
Bioimpedance Percentage Difference Healthy/Operated
Baseline limb bioimpedance R0 difference (%)
|
1.8 percentage difference between limbs
Standard Deviation 5.0
|
0.2 percentage difference between limbs
Standard Deviation 4.5
|
|
Bioimpedance Percentage Difference Healthy/Operated
Limb bioimpedance R0 difference at day 2 (%)
|
12.9 percentage difference between limbs
Standard Deviation 9.7
|
13.7 percentage difference between limbs
Standard Deviation 72
|
|
Bioimpedance Percentage Difference Healthy/Operated
Limb bioimpedance R0 difference at day 7 (%)
|
41.8 percentage difference between limbs
Standard Deviation 6.5
|
40.8 percentage difference between limbs
Standard Deviation 6.6
|
|
Bioimpedance Percentage Difference Healthy/Operated
Limb bioimpedance R0 difference at 3 months (%)
|
16.6 percentage difference between limbs
Standard Deviation 9.3
|
19.1 percentage difference between limbs
Standard Deviation 11.0
|
PRIMARY outcome
Timeframe: presurgery, and 2 days, 7 days and 3 months after surgeryPopulation: At day 7, 3 patients lost at follow up in the control group and 1 in the treatment group. At 3 months, 3 more patients lost at follow up in the control group.
The limb volume was evaluated for each limb using circumferential tape measurements at 4 cm intervals. Then the tape measurementy were converted into limb volume using the validated truncated-cone method, and the percentage difference between the operated and the healthy limb was calculated.
Outcome measures
| Measure |
Placebo
n=30 Participants
Patients who received relaxation as placebo intervention
|
Manual Lymphatic Drainage
n=30 Participants
Patients who received manual lymphatic drainage as the study intervention
|
|---|---|---|
|
Lower Limb Volume Percentage Difference Operated/Healthy
Baseline limb volume difference (%)
|
1.8 percentage difference between limbs
Standard Deviation 5.0
|
0. percentage difference between limbs
Standard Deviation 4.5
|
|
Lower Limb Volume Percentage Difference Operated/Healthy
Limb volume difference at day 2 (%)
|
12.9 percentage difference between limbs
Standard Deviation 9.7
|
13.7 percentage difference between limbs
Standard Deviation 7.2
|
|
Lower Limb Volume Percentage Difference Operated/Healthy
Limb volume difference at day 7 (%)
|
17.0 percentage difference between limbs
Standard Deviation 10.7
|
15.3 percentage difference between limbs
Standard Deviation 6.5
|
|
Lower Limb Volume Percentage Difference Operated/Healthy
Limb volume difference at 3 months (%)
|
3.7 percentage difference between limbs
Standard Deviation 5.7
|
4.1 percentage difference between limbs
Standard Deviation 5.1
|
Adverse Events
Manual Lymphatic Drainage
Relaxation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place