Knee Arthroplasty, Total
Conditions
Keywords
Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome
Brief summary
The purpose of this study is to evaluate the efficiency of manual lymphatic drainage to decrease the swelling of the knee after total knee replacement surgery
Detailed description
Background There is scientific evidence that rehabilitation has a positive influence on patients'recovery after total knee arthroplasty (TKA). According to the literature, conventional rehabilitation aims to improve knee range of motion, lower limb strength, gait, activities and pain. Although swelling is a systematic consequence of TKA surgery, less focus is put on swelling reduction. Patients develop swelling due to periarticular edema, hematoma and joint effusion. Inflammation, pain, stiffness, alteration of gait pattern, quadriceps contraction inhibition and slowing of rehabilitation are reported as consequences of swelling. Accordingly, it is likely that a therapy that would promote resorption of swelling would decrease the negative impact of swelling on patients'recovery. Manual lymph drainage (MLD) could possibly accelerate edema resorption after TKA surgery. Several authors advise MLD after TKA, and physiotherapists currently apply MLD to reduce postsurgical swelling. Its positive effect on chronic lymphedema resorption is largely accepted. Results on pain and range of motion seem interesting from an empirical point of view but, to our knowledge, no scientifically driven studies have confirmed these positive effects after orthopaedic surgery. Aim This study aims to evaluate the effect of MLD on swelling, and parameters possibly influenced by swelling (pain, knee range of motion, knee objective and subjective function and gait pattern). Methods This study is a randomized controlled clinical trial. Patients will be blinded from goals of the treatments and evaluators will be blinded from the treatment delivered to the patient. The effects of MLD (5 treatments of 30 minutes from the second to the eighth postsurgical day) will be compared to those of a placebo (relaxation sessions). MLD or placebo will be added to the conventional rehabilitation program of our Orthopaedic Department. Assessments will be conducted one day before surgery, two days, 8 days and 3 months after surgery. Evolution and differences between groups will be statistically assessed at each step. Significance This project aims to improve knowledge on the efficiency of rehabilitation treatments following TKA. It will contribute to effective evaluation of the effects of a widely applied treatment. The results will help physiotherapists and medical doctors to take clinical decisions based on documented evidence. This will make a contribution to better quality of care and better allocation of resources to rehabilitation.
Interventions
OTHERManual lymphatic drainage
Each patient will receive 5 treatments of 30 minutes by a trained physiotherapist, from day 2 to day 7 post surgery
OTHERrelaxation
Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery
Sponsors
University of Applied Sciences of Western Switzerland
University of Lausanne Hospitals
Haute Ecole de Santé Vaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* knee replacement surgery
Exclusion criteria
* pacemaker * cardiac defibrillator * pathology of the lymphatic system * lower limb impairment which interferes with gait * neurological disease * unability to understand patient information letter or to give informed consent * unability to understand and complete questionnaires in French * contraindication to manual lymphatic drainage : thrombosis, infection, right cardiac insufficiency, active cancer * non standard knee replacement surgery * high dose anticoagulation * post surgical complication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioimpedance Percentage Difference Healthy/Operated | presurgery, 2 days, 7 days and 3 months post surgery | 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. |
| Lower Limb Volume Percentage Difference Operated/Healthy | presurgery, and 2 days, 7 days and 3 months after surgery | 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. |
Countries
Switzerland
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Relaxation | Manual Lymphatic Drainage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 23 Participants | 44 Participants |
| Age, Continuous | 70.1 years STANDARD_DEVIATION 9.1 | 71.3 years STANDARD_DEVIATION 8.5 | 70.7 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Switzerland | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Bioimpedance Percentage Difference Healthy/Operated
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.
Time frame: presurgery, 2 days, 7 days and 3 months post surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Bioimpedance Percentage Difference Healthy/Operated | Baseline limb bioimpedance R0 difference (%) | 1.8 percentage difference between limbs | Standard Deviation 5 |
| Placebo | Bioimpedance Percentage Difference Healthy/Operated | Limb bioimpedance R0 difference at day 2 (%) | 12.9 percentage difference between limbs | Standard Deviation 9.7 |
| Placebo | Bioimpedance Percentage Difference Healthy/Operated | Limb bioimpedance R0 difference at day 7 (%) | 41.8 percentage difference between limbs | Standard Deviation 6.5 |
| Placebo | Bioimpedance Percentage Difference Healthy/Operated | Limb bioimpedance R0 difference at 3 months (%) | 16.6 percentage difference between limbs | Standard Deviation 9.3 |
| Manual Lymphatic Drainage | Bioimpedance Percentage Difference Healthy/Operated | Limb bioimpedance R0 difference at 3 months (%) | 19.1 percentage difference between limbs | Standard Deviation 11 |
| Manual Lymphatic Drainage | Bioimpedance Percentage Difference Healthy/Operated | Baseline limb bioimpedance R0 difference (%) | 0.2 percentage difference between limbs | Standard Deviation 4.5 |
| Manual Lymphatic Drainage | Bioimpedance Percentage Difference Healthy/Operated | Limb bioimpedance R0 difference at day 7 (%) | 40.8 percentage difference between limbs | Standard Deviation 6.6 |
| Manual Lymphatic Drainage | Bioimpedance Percentage Difference Healthy/Operated | Limb bioimpedance R0 difference at day 2 (%) | 13.7 percentage difference between limbs | Standard Deviation 72 |
Comparison: All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.p-value: 0.51Wilcoxon (Mann-Whitney)
Primary
Lower Limb Volume Percentage Difference Operated/Healthy
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.
Time frame: presurgery, and 2 days, 7 days and 3 months after surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Lower Limb Volume Percentage Difference Operated/Healthy | Baseline limb volume difference (%) | 1.8 percentage difference between limbs | Standard Deviation 5 |
| Placebo | Lower Limb Volume Percentage Difference Operated/Healthy | Limb volume difference at day 2 (%) | 12.9 percentage difference between limbs | Standard Deviation 9.7 |
| Placebo | Lower Limb Volume Percentage Difference Operated/Healthy | Limb volume difference at day 7 (%) | 17.0 percentage difference between limbs | Standard Deviation 10.7 |
| Placebo | Lower Limb Volume Percentage Difference Operated/Healthy | Limb volume difference at 3 months (%) | 3.7 percentage difference between limbs | Standard Deviation 5.7 |
| Manual Lymphatic Drainage | Lower Limb Volume Percentage Difference Operated/Healthy | Limb volume difference at 3 months (%) | 4.1 percentage difference between limbs | Standard Deviation 5.1 |
| Manual Lymphatic Drainage | Lower Limb Volume Percentage Difference Operated/Healthy | Baseline limb volume difference (%) | 0. percentage difference between limbs | Standard Deviation 4.5 |
| Manual Lymphatic Drainage | Lower Limb Volume Percentage Difference Operated/Healthy | Limb volume difference at day 7 (%) | 15.3 percentage difference between limbs | Standard Deviation 6.5 |
| Manual Lymphatic Drainage | Lower Limb Volume Percentage Difference Operated/Healthy | Limb volume difference at day 2 (%) | 13.7 percentage difference between limbs | Standard Deviation 7.2 |
Comparison: All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.p-value: 0.58Wilcoxon (Mann-Whitney)