Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

Knee Arthroplasty, Total Clinical Trial

Official title:

Outcome of Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711711
• Other study ID #: FNS-DORE 13DPD3-120298
• Secondary ID: SAGEX: 21267RéSa
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: March 2011

Study information

• Verified date: August 2018
• Source: Haute Ecole de Santé Vaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

Other:
• 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
Each patient will receive 5 treatments of 30 minutes of tape recorded relaxation , from day 2 to day 7 post surgery

Locations

Country	Name	City	State
Switzerland	Département de l'Appareil Locomoteur - CHUV	Lausanne
Switzerland	Haute Ecole Cantonale Vaudoise de Santé	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
Haute Ecole de Santé Vaud	University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	presurgery, 2 days, 7 days and 3 months post surgery
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.	presurgery, and 2 days, 7 days and 3 months after surgery