EdemaNCT03490409
Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty
A study testing Thigh compression stocking in people with Edema, run by Naestved Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema
- What is being tested?
- Thigh compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Dec 2017to 9 Apr 2018
- 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
- Planned for total knee arthroplasty
- BMI ≥30 kg/m2, aged 18 or older
- Speaks, reads and understands Danish
- Written informed consent.
Who cannot join
- Peripheral Arterial Disease
- Arterial insufficiency
- No palpable puls at the arteria dorsalis pedis
- Severe atherosclerosis
- Leg ulcers
- Skin disease
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Edema
- Being tested
- Thigh compression stocking
- Keywords
- Arthroplasty, Replacement, Knee, Compression, Edema, Pain
- Medical subject headings
- Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thigh compression stockingDevice
Thigh compression stocking
| Study group | Role | What they receive |
|---|---|---|
| compression stocking | Experimental | The intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery. Receives: Device: Thigh compression stocking |
| Conventional treatment | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery
Secondary outcomes (3)
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.
Measured: Assessment of swelling of the calf from baseline and 1, 2, 14 days after surgery
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.
Measured: Assessment of the swelling of the ankle from baseline and 1, 2, 14 days after surgery
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.
Measured: Assessment of pain from baseline and 1, 2, 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start18 Dec 2017
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Mie Christensen, Naestved Hospital
- Investigators
- Linda Mie Christensen, nurse, Principal investigator, Naestved Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490409
- Sponsor's protocol ID
- SJ-635
- Status last verified
- Jun 2018
- First submitted
- 1 Dec 2017
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03490409
- Acronym / sponsor ID
- SJ-635
- Conditions
- Edema
- Keywords
- Arthroplasty, Replacement, Knee, Compression, Edema, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 6 Apr 2018 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compression stocking | Experimental | Device: Thigh compression stockingThe intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery. |
| Conventional treatment | No intervention | –The control group will receive conventional treatment, a compression bandage placed at the end of surgery and removed on the night of the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned for total knee arthroplasty
- BMI ≥30 kg/m2, aged 18 or older
- Speaks, reads and understands Danish
- Written informed consent.
Key exclusion criteria (13 listed)
- Peripheral Arterial Disease
- Arterial insufficiency
- No palpable puls at the arteria dorsalis pedis
- Severe atherosclerosis
- Leg ulcers
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 |
|---|---|---|
| Thigh compression stockingThigh compression stocking | Device | compression stocking |
Primary outcome
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.
3 secondary outcomes
Swelling of the calf after the operation.
Time frame: 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
Pain after the operation.
Time frame: Assessment of pain from baseline and 1, 2, 14 days after surgery
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 11 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Linda Mie Christensen, nurse principal investigator
Naestved Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thigh compression stocking in people with Edema, run by Naestved Hospital at 1 site in Denmark.
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 4 inclusion and 13 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 11 Jun 2018. 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 Denmark. 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?
Swelling of the knee after operation (time frame: Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2018.