LymphedemaPhase 4NCT02375945
Comparison Between a Non-elastic Falcro Device and Current Method After Total Knee Arthroplasty
A Phase 4 study testing New non-elastic compression kit and current compression stocking Comprinet® in people with Lymphedema, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
Trial summary
Swelling is a common problem after knee arthroplasty often leading to delayed wound healing, lasting functional impairment and hematoma. Due to this complications, sometimes the risk for deep venous thrombosis is raised. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- New non-elastic compression kit and current compression stocking Comprinet®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to Jul 2016
- Phase
- Phase 4
- 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
- 18 years of age or older
- Patients undergoing a primary elective total knee arthroplasty
- The patient is able to understand the study and is willing to give written informed consent to the study.
Who cannot join
- Allergy against one of the used materials
- Severe systemic diseases causing peripheral oedema
- Acute superficial or deep vein thrombosis
- Arterial occlusive disease (stadium II, III or IV) ABPI<0,8
- Local infection in the therapy area
- auto-immunological disorders or vasculitis
- use of systemic corticosteroids
- Inability to don, doff, and adjust the device
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Nij Smellinghe hospital
Drachten, Provincie Friesland, 9202 NN
About this study
Official title: Prospective, Randomized Controlled Trial Comparing the Effect of a Non-elastic Compression Device Juxta Reduction Kit (Medi ®)" Versus Elastic Class 1 Stockings (BSN Medical® in Patients Undergoing Total Knee Arthroplasty
Swelling is a common problem after knee arthroplasty often leading to delayed wound healing, lasting functional impairment and hematoma.
Due to this complications, sometimes the risk for deep venous thrombosis is raised. This study investigates a new self adjustable device to reduce swelling more effective postoperatively. The investigators compare the new device to the current general practice by using a standard class 1 elastic stocking
Read the detailed description
Purpose Pain, swelling and inflammation are expected during early recovery from total knee arthroplasty (TKA). Compression therapy is a frequently used modality in the direct post operative treatment, but there is a great variety in the use of materials, the way and time frame of application. The most common goals of the compression therapy are prevention and reduction of the swelling. At the same time the literature is not consistent about the use and effects of compression therapy other than for prevention of trombo-embolic processes The state of the art care concepts for patients undergoing a total knee arthroplasty embraces the concept of "fast track" (Kehlet et al) with important parts as early mobilisation and optimal analgesics. In the investigators hospital this concept has already been implemented.
During the stay in the hospital the challenge is to give adequate compression therapy to prevent and reduce swelling and enhance woundhealing. At the same time it is essential to optimise ambulation of the patient and the possibilities to exercise.
The current protocol in the investigators hospital consists of 24 hours compression therapy with "Elastomull Haft ®", an elastic bandage for the knee region, combined with a Comprinet stocking (BSM Medical®) for anti thrombotic purposis. The anti thrombosis stocking is worn for a period of 6 weeks.
The compression is combined with the use of the Continious Passive Motion device for 4 hours post operatively (2 hours immobilisation in a position of 90 degrees flexion, followed by 2 hours hours of passive motion in a range of 60-90 degrees flexion). Four hours post operatively the patient is ambulatend and the physical therapy starts.
The investigators wonder if this is the optimal way of post-operative care. Swelling of the knee and the whole leg can remain a problem in the first 6 weeks of recovery which inhibits rehabilitation. Sometimes delayed woundhealing will occur and patients may complain of more durable pain which make analgesics necessary.
Prolonging adequate compression could improve the post-operative course and support the total rehabilitation process.
The "Juxta Reduction Kit (by Medi) ®" , applied for the knee could be an adequate solution to replace the current protocol of compression therapy.
The "Juxta Reduction Kit ®" is a non-elastic compression device which can be tailored (by cutting it to the correct size) to the circumference of the leg prior to the operation. Direct post operatively the compression device can be adjusted by the staff and in the following days patients are enabled to adjust the device by themselves by using the Velcro ties to loosen or fasten it.
The device is suitable in early mobilisation and gives the patient tools for selfmanagement of the compression by using the Velcro flaps. The material doesn't restrict the range of motion and so the possibility to ambulate and to exercise as advised in the fast track concept is optimised.
In this study the patients will use the compression device for a period of six weeks in combination with an anti thrombosis stocking (Struva class 2) Outcome parameters will be measured in a scheduled way, described in scheme 1.
- Conditions
- Lymphedema
- Being tested
- New non-elastic compression kit, current compression stocking Comprinet®
- Keywords
- lymphedema, post operative compression treatment, compression therapy, adjustable fulcro wraps, edema
- Medical subject headings
- Lymphedema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New non-elastic compression kitDevice
Also called study material
Comparison of new non-elastic bandage kit with the currently accepted method
current compression stocking Comprinet®Device
Comparison of new non-elastic bandage kit with the currently accepted method
| Study group | Role | What they receive |
|---|---|---|
| current compression stocking Comprinet® | Active comparator | Immediately post operatively 24 hours compression therapy starts with "Elastomull Haft ®", an elastic bandage, combined with a Comprinet stocking (BSM Medical®) for anti thrombotic purposes. The anti thrombosis stocking is worn 6 weeks post operatively. After 4 hours the patient is ambulated and the physical therapy starts. Receives: Device: New non-elastic compression kit; Device: current compression stocking Comprinet® |
| New non-elastic compression kit | Experimental | Juxta Reduction Kit ® Immediately post operative compression starts with the Juxta Reduction Kit® for the knee region, combined with an anti thrombosis stocking (Struva 2, for prevention of trombo-embolism). Both the stocking and the Juxtra Pro are used for six weeks. After 4 hours the patient ambulated and the physical therapy starts.
For the first 24 hours and longer if necessary (depending on the skills of the patient) Juxta experienced staff will apply the device and the fit and the use of the device will be checked.
In the second phase between approximately 24 hours and 6 weeks patients may adjust the Juxta-pro according to their needs and comfort by themselves. Receives: Device: New non-elastic compression kit; Device: current compression stocking Comprinet® |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of the device on wound healing, swelling reduction and functional improvement
efficacy of the device on wound healing, swelling reduction and functional improvement
Measured: 12 weeks
circumference measurements
efficacy of the device
Measured: 12 weeks
Secondary outcomes (1)
comfort to the patient / QoL
The effects and wearing comfort to the patient is closely recorded. Further the number of adjustment of the device by the patient and his/her experience
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nij Smellinghe Hosptial
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J. Damstra, Nij Smellinghe Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375945
- Sponsor's protocol ID
- NS7NL
- Status last verified
- Sep 2016
- First submitted
- 7 Feb 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Trial Comparing the Effect of a Non-elastic Compression Device Juxta Reduction Kit (Medi ®)" Versus Elastic Class 1 Stockings (BSN Medical® in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02375945
- Acronym / sponsor ID
- NS7NL
- Conditions
- Lymphedema
- Keywords
- lymphedema, post operative compression treatment, compression therapy, adjustable fulcro wraps, edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nij Smellinghe HosptialUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
Swelling is a common problem after knee arthroplasty often leading to delayed wound healing, lasting functional impairment and hematoma.
Due to this complications, sometimes the risk for deep venous thrombosis is raised. This study investigates a new self adjustable device to reduce swelling more effective postoperatively. The investigators compare the new device to the current general practice by using a standard class 1 elastic stocking
Detailed description
Purpose Pain, swelling and inflammation are expected during early recovery from total knee arthroplasty (TKA). Compression therapy is a frequently used modality in the direct post operative treatment, but there is a great variety in the use of materials, the way and time frame of application. The most common goals of the compression therapy are prevention and reduction of the swelling. At the same time the literature is not consistent about the use and effects of compression therapy other than for prevention of trombo-embolic processes The state of the art care concepts for patients undergoing a total knee arthroplasty embraces the concept of "fast track" (Kehlet et al) with important parts as early mobilisation and optimal analgesics. In the investigators hospital this concept has already been implemented.
During the stay in the hospital the challenge is to give adequate compression therapy to prevent and reduce swelling and enhance woundhealing. At the same time it is essential to optimise ambulation of the patient and the possibilities to exercise.
The current protocol in the investigators hospital consists of 24 hours compression therapy with "Elastomull Haft ®", an elastic bandage for the knee region, combined with a Comprinet stocking (BSM Medical®) for anti thrombotic purposis. The anti thrombosis stocking is worn for a period of 6 weeks.
The compression is combined with the use of the Continious Passive Motion device for 4 hours post operatively (2 hours immobilisation in a position of 90 degrees flexion, followed by 2 hours hours of passive motion in a range of 60-90 degrees flexion). Four hours post operatively the patient is ambulatend and the physical therapy starts.
The investigators wonder if this is the optimal way of post-operative care. Swelling of the knee and the whole leg can remain a problem in the first 6 weeks of recovery which inhibits rehabilitation. Sometimes delayed woundhealing will occur and patients may complain of more durable pain which make analgesics necessary.
Prolonging adequate compression could improve the post-operative course and support the total rehabilitation process.
The "Juxta Reduction Kit (by Medi) ®" , applied for the knee could be an adequate solution to replace the current protocol of compression therapy.
The "Juxta Reduction Kit ®" is a non-elastic compression device which can be tailored (by cutting it to the correct size) to the circumference of the leg prior to the operation. Direct post operatively the compression device can be adjusted by the staff and in the following days patients are enabled to adjust the device by themselves by using the Velcro ties to loosen or fasten it.
The device is suitable in early mobilisation and gives the patient tools for selfmanagement of the compression by using the Velcro flaps. The material doesn't restrict the range of motion and so the possibility to ambulate and to exercise as advised in the fast track concept is optimised.
In this study the patients will use the compression device for a period of six weeks in combination with an anti thrombosis stocking (Struva class 2) Outcome parameters will be measured in a scheduled way, described in scheme 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| current compression stocking Comprinet® | Active comparator | Device: New non-elastic compression kit, Device: current compression stocking Comprinet®Immediately post operatively 24 hours compression therapy starts with "Elastomull Haft ®", an elastic bandage, combined with a Comprinet stocking (BSM Medical®) for anti thrombotic purposes. The anti thrombosis stocking is worn 6 weeks post operatively. After 4 hours the patient is ambulated and the physical therapy starts. |
| New non-elastic compression kit | Experimental | Device: New non-elastic compression kit, Device: current compression stocking Comprinet®Juxta Reduction Kit ® Immediately post operative compression starts with the Juxta Reduction Kit® for the knee region, combined with an anti thrombosis stocking (Struva 2, for prevention of trombo-embolism). Both the stocking and the Juxtra Pro are used for six weeks. After 4 hours the patient ambulated and the physical therapy starts. For the first 24 hours and longer if necessary (depending on the skills of the patient) Juxta experienced staff will apply the device and the fit and the use of the device will be checked. In the second phase between approximately 24 hours and 6 weeks patients may adjust the Juxta-pro according to their needs and comfort by themselves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients undergoing a primary elective total knee arthroplasty
- The patient is able to understand the study and is willing to give written informed consent to the study.
Key exclusion criteria (8 listed)
- Allergy against one of the used materials
- Severe systemic diseases causing peripheral oedema
- Acute superficial or deep vein thrombosis
- Arterial occlusive disease (stadium II, III or IV) ABPI<0,8
- Local infection in the therapy area
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 |
|---|---|---|
| New non-elastic compression kitAlso: study materialComparison of new non-elastic bandage kit with the currently accepted method | Device | New non-elastic compression kit, current compression stocking Comprinet® |
| current compression stocking Comprinet®Comparison of new non-elastic bandage kit with the currently accepted method | Device | New non-elastic compression kit, current compression stocking Comprinet® |
Primary outcome
efficacy of the device on wound healing, swelling reduction and functional improvement
Time frame: 12 weeks
efficacy of the device on wound healing, swelling reduction and functional improvement
circumference measurements
Time frame: 12 weeks
efficacy of the device
1 secondary outcome
comfort to the patient / QoL
Time frame: 12 weeks
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 27 Sep 2016.
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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.
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 Phase 4 study testing New non-elastic compression kit and current compression stocking Comprinet® in people with Lymphedema, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
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 3 inclusion and 8 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 27 Sep 2016. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy of the device on wound healing, swelling reduction and functional improvement (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 27 Sep 2016.