Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty
Primary Purpose
Edema
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Thigh compression stocking
Sponsored by
About this trial
This is an interventional prevention trial for Edema focused on measuring Arthroplasty, Replacement, Knee, Compression, Edema, Pain
Eligibility Criteria
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
Sites / Locations
- Department for planned Orthopaedic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
compression stocking
Conventional treatment
Arm Description
The intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery.
The control group will receive conventional treatment, a compression bandage placed at the end of surgery and removed on the night of the surgery.
Outcomes
Primary Outcome Measures
Swelling of the knee after operation
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.
Secondary Outcome Measures
Swelling of the calf after the operation.
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.
Swelling of the ankle after the operation.
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.
Pain after the operation.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03490409
Brief Title
Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Naestved Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema
Keywords
Arthroplasty, Replacement, Knee, Compression, Edema, Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
compression stocking
Arm Type
Experimental
Arm Description
The intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery.
Arm Title
Conventional treatment
Arm Type
No Intervention
Arm Description
The control group will receive conventional treatment, a compression bandage placed at the end of surgery and removed on the night of the surgery.
Intervention Type
Device
Intervention Name(s)
Thigh compression stocking
Intervention Description
Thigh compression stocking
Primary Outcome Measure Information:
Title
Swelling of the knee after operation
Description
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.
Time Frame
Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery
Secondary Outcome Measure Information:
Title
Swelling of the calf after the operation.
Description
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.
Time Frame
Assessment of swelling of the calf from baseline and 1, 2, 14 days after surgery
Title
Swelling of the ankle after the operation.
Description
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.
Time Frame
Assessment of the swelling of the ankle from baseline and 1, 2, 14 days after surgery
Title
Pain after the operation.
Description
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.
Time Frame
Assessment of pain from baseline and 1, 2, 14 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Mie Christensen, nurse
Organizational Affiliation
Naestved Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for planned Orthopaedic Surgery
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty
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