Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty

June 8, 2018 updated by: Linda Mie Christensen, Naestved Hospital

Effect of Compression Therapy on Postoperative Swelling and Pain, Among Patients With a BMI ≥30 kg/m2, After Total Knee Arthroplasty: A Randomized Controlled Pilot Study

The number of severely obese patients who has knee replacement surgery is rising. Obesity increases the risk of the postoperative swelling. A complication which can cause pain and discomfort as well as complicate and prolong rehabilitation.

The aim of the present pilot study is to examine the effect of a compression stocking on postoperative swelling and pain among patients with a BMI ≥30 kg/m2, after total knee arthroplasty. The hypothesis is that the use of a medical elastic compression stocking for 14 days postoperatively may reduce postoperative swelling by two cm.

The pilot study will furthermore provide useful information for feasibility which will be used to decide whether or not a larger study should be initiated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In Denmark approximately 9000 knee replacements were performed in 2015. Almost 7000 of the procedures performed were total knee arthroplasties.

A total knee arthroplasty is a common procedure performed as treatment for knee arthritis.

In 2015, 39,9% of the patients in Denmark who had knee replacement surgery were severely obese with a BMI ≥30 kg/m2.

The percentage of severely obese patients who has knee replacement surgery is rising and studies have shown that obesity increases the risk of postoperative complications.

A danish cross-sectional study found that swelling with a prevalence of 90,7% was the most frequent patient-reported complication after knee arthroplasty. A common postoperative complication after total knee arthroplasty and severe obesity increases the risk of postoperative swelling.

Postoperative swelling may impair movement of the knee, cause pain and discomfort as well as complicate and prolong rehabilitation.

Despite that a BMI 30 kg/m2 causes more postoperative complications, obese patients experience the same quality of life and improvement of function after total knee arthroplasty as patients with a BMI ≤30 kg/m2. The higher complication rate among the obese patients has socioeconomic consequences due to readmission and unscheduled outpatient visits.

A study found that in the first 30 days postoperative after total knee arthroplasty 2,9 percent of the patients were readmitted. In 2015 7,3% of the patients who had primary knee replacement surgery in Denmark were readmitted within 30 days after the operation. Unscheduled outpatient visits 30 days post-surgery, is related to swelling in the operated leg. There is a need for further research on interventions that may prevent postoperative swelling after knee replacement surgery. A compression stocking is a feasible intervention and an effective treatment in the prevention of swelling. The stocking provides measured pressure against the leg which helps the blood to move up toward the heart. By improving the blood flow, swelling is prevented and reduced.

A Danish randomized controlled study (RCT), that investigated the effect of a compression stocking when used for four weeks postoperatively found that the stocking did not have a clinical effect on postoperative swelling.

However the stocking was the day after the surgery, where seventy percent of the postoperative swelling already had occurred.

Therefore it is relevant to investigate whether a compression stocking has an effect on postoperative swelling, when applied immediately after the operation has ended.

The aim of the present pilot study is to examine the effect of a compression stocking on postoperative swelling and pain among patients with a BMI ≥30 kg/m2, after total knee arthroplasty. The aim of the pilot study is furthermore to provide useful information for feasibility which will be used to decide whether or not a larger RCT should be initiated.

All patients will be recruited at Department for planned Orthopaedic Surgery, Naestved Hospital, Denmark.

Inclusion criteria: planned for total knee arthroplasty, BMI ≥30 kg/m2, aged 18 or older, speaks, reads and understands danish and written informed consent.

Collaborating researchers and departments :

Department for Planned Orthopaedic Surgery, Ringstedgade 61, Naestved Hospital, Denmark.

Odense Patient data Explorative Network, J.B. Winsloew Vej 9a, 3. Sal, 5000 Odense C, Denmark

44 patients will be included in the pilot study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Naestved, Denmark, 4700
        • Department for planned Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Planned for total knee arthroplasty
  • BMI ≥30 kg/m2, aged 18 or older
  • Speaks, reads and understands Danish
  • Written informed consent.

Exclusion Criteria:

  • Peripheral Arterial Disease
  • Arterial insufficiency
  • No palpable puls at the arteria dorsalis pedis
  • Severe atherosclerosis
  • Leg ulcers
  • Skin disease
  • Fragile "tissue paper" skin
  • Neuropathy or other cause of sensory impairment
  • Allergy to the stocking material
  • Massive leg edema or pulmonary edema from congestive cardiac failure,
  • Deformity of the leg or unusual leg shape or size preventing correct fit
  • Patient that cannot cooperate. For example does not understand the concept of Visual Analogue Scale (VAS) or is not able to use the compression stocking
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: compression stocking
The intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery.
Device: Thigh compression stocking
Thigh compression stocking
No Intervention: Conventional treatment
The control group will receive conventional treatment, a compression bandage placed at the end of surgery and removed on the night of the surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Swelling of the knee after operation
Time Frame: Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery
Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.
Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Swelling of the calf after the operation.
Time Frame: Assessment of swelling of the calf from baseline and 1, 2, 14 days after surgery
Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.
Assessment of swelling of the calf from baseline and 1, 2, 14 days after surgery
Swelling of the ankle after the operation.
Time Frame: Assessment of the swelling of the ankle from baseline and 1, 2, 14 days after surgery
Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.
Assessment of the swelling of the ankle from baseline and 1, 2, 14 days after surgery
Pain after the operation.
Time Frame: Assessment of pain from baseline and 1, 2, 14 days after surgery
Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery using Visual Analogue Scale. A pain measurement scale. Minimum score is 0 and maximum score is 100. Higher values represent a worse outcome. Lower values represents a better outcome.
Assessment of pain from baseline and 1, 2, 14 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Naestved Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linda Mie Christensen, nurse, Naestved Sygehus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJ-635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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