Total Knee ArthroplastyNCT05119764

Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial

A study testing Manual Lymphatic Drainage in people with Total Knee Arthroplasty and Manual Lymphatic Drainage, run by Moritz Wagner at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this observer-blinded randomized controlled trial is the evaluation of the influence of manual lymphatic drainage (MLD) on the outcome of patients receiving total knee replacement (TKA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Total Knee Arthroplasty, Manual Lymphatic Drainage, MLD
What is being tested?: Manual Lymphatic Drainage
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteAustria
Study dates: 1 Mar 2021to 8 Feb 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Total Knee Arthroplasty (TKA)

Who cannot join

Venous insufficiency
BMI > 38
Vascular disease

Trial locations and contacts

1 site in 1 country.

Austria1 site

BKH St. Johann in Tirol
Sankt Johann in Tirol, Tyrol, 6380

Other trials in Austria

About this study

The aim of this observer-blinded randomized controlled trial is the evaluation of the influence of manual lymphatic drainage (MLD) on the outcome of patients receiving total knee replacement (TKA).

Conditions: Total Knee Arthroplasty, Manual Lymphatic Drainage, MLD, Rehabilitation, Knee Osteoarthritis
Being tested: Manual Lymphatic Drainage
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manual Lymphatic DrainageProcedure or surgery
Manual Lymphatic Drainage is a form of physical therapy with the primary goal of accelerating lymphatic drainage.
In this study, the manual lymphatic drainage is applied by experienced physical therapists 5 days in a row for 30 minutes each; after and/or before the surgery.

Study groups in NCT05119764
Study group	Role	What they receive
Control Group	No intervention	Standard pre- and postoperative physical therapy without manual lymphatic drainage.
Manual lymphatic drainage before and after knee replacement	Experimental	Manual lymphatic drainage before and after knee replacement Receives: Procedure: Manual Lymphatic Drainage
Manual lymphatic drainage after knee replacement	Experimental	Manual lymphatic drainage after knee replacement Receives: Procedure: Manual Lymphatic Drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

Volume
The swelling/volume is calculated through measurements of the circumference at 7 distinct points of the leg. The unit is [mm].
Measured: Change in swelling weeks before the operation to one year after the operation
Function
Knee range of motion (ROM), active and passive. The unit is [degrees]
Measured: Change in ROM weeks before the operation to one year after the operation
Knee Pain
Visual analogue scale from 0 to 10 on the average level of knee pain in the last 24 hours.
Measured: Change in pain weeks before the operation to one year after the operation

Secondary outcomes (1)

Subjective patient reported outcome
WOMAC Score (Western Ontario and McMaster University Osteoarthritis Index)
Measured: Before the operation, five days after the operation and one year after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20218 Feb 2023

First posted15 Nov 2021
Study start1 Mar 2021
Primary completion1 Feb 2023
Study completion8 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled trial with three treatment groups, two intervention groups and one control group
Masking: Single blind
Who is masked: Investigator
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05119764
Sponsor's protocol ID: 1466/2020
Status last verified: Aug 2023
First submitted: 12 May 2021
Last updated: 2 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty

All Total Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05119764
Acronym / sponsor ID: 1466/2020
Conditions: Total Knee Arthroplasty, Manual Lymphatic Drainage, MLD, Rehabilitation, Knee Osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Moritz WagnerUniversity, hospital or other
Collaborators: Bezirkskrankenhaus St. Johann in Tirol
Study start: 1 Mar 2021 (actual)
Primary completion: 1 Feb 2023 (actual)
Study completion: 8 Feb 2023 (actual)
First posted: 15 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this observer-blinded randomized controlled trial is the evaluation of the influence of manual lymphatic drainage (MLD) on the outcome of patients receiving total knee replacement (TKA).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3
Model description: Randomized controlled trial with three treatment groups, two intervention groups and one control group

Arm	Type	Receives
Control Group	No intervention	–Standard pre- and postoperative physical therapy without manual lymphatic drainage.
Manual lymphatic drainage before and after knee replacement	Experimental	Procedure: Manual Lymphatic DrainageManual lymphatic drainage before and after knee replacement
Manual lymphatic drainage after knee replacement	Experimental	Procedure: Manual Lymphatic DrainageManual lymphatic drainage after knee replacement

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Total Knee Arthroplasty (TKA)

Key exclusion criteria (3 listed)

Venous insufficiency
BMI > 38
Vascular disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Manual Lymphatic DrainageManual Lymphatic Drainage is a form of physical therapy with the primary goal of accelerating lymphatic drainage. In this study, the manual lymphatic drainage is applied by experienced physical therapists 5 days in a row for 30 minutes each; after and/or before the surgery.	Procedure or surgery	Manual lymphatic drainage after knee replacement, Manual lymphatic drainage before and after knee replacement

Primary outcome

Volume
Time frame: Change in swelling weeks before the operation to one year after the operation
The swelling/volume is calculated through measurements of the circumference at 7 distinct points of the leg. The unit is [mm].
Function
Time frame: Change in ROM weeks before the operation to one year after the operation
Knee range of motion (ROM), active and passive. The unit is [degrees]
Knee Pain
Time frame: Change in pain weeks before the operation to one year after the operation
Visual analogue scale from 0 to 10 on the average level of knee pain in the last 24 hours.

1 secondary outcome

Subjective patient reported outcome
Time frame: Before the operation, five days after the operation and one year after the operation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Individual participant dataSharing planned: Undecided

Related trials for Total Knee Arthroplasty

Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Manual Lymphatic Drainage in people with Total Knee Arthroplasty and Manual Lymphatic Drainage, run by Moritz Wagner at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume (time frame: Change in swelling weeks before the operation to one year after the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05119764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.