Compliance of Wearing of Compressive StockingsNCT04434222
Compressive Stockings Therapy After TKA
A study testing Compressive stockings in people with Compliance of Wearing of Compressive Stockings and Total Knee Arthroplasty, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compliance of Wearing of Compressive Stockings, Total Knee Arthroplasty
- What is being tested?
- Compressive stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2019to 30 May 2022
- 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
- Patients receiving a total knee replacement
- Written consent of the study participant
Who cannot join
- Peripheral arterial disease II, III or IV
- Diabetes mellitus
- Systemic inflammatory diseases
- Benign or malignant neoplasms
- Revision interventions
- Right heart failure
- pulmonary edema
- Open / chronic skin lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Compliance Controlled Postoperative Compressive Stockings Therapy After Total Knee Arthroplasty: a Randomized Controlled Trial
Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative swelling and pain and furthermore improve mobilization and knee function.
In this randomized controlled trial, 88 patients are randomized in two groups. One group receives postoperatively compressive stockings for a period of 6 weeks. The control group is treated without compressive stockings. The patients compressive stockings wearing compliance is controlled with a temperature sensitive sensor. The patients will be informed about the implantation of the sensor.
Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score preoperatively and at 12 weeks, 12 months and 24 months.
- Being tested
- Compressive stockings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressive stockingsDevice
Compressive stockings with built in Orthotimer Sensor
| Study group | Role | What they receive |
|---|---|---|
| Compressive stockings group | Active comparator | Group receives postoperatively compressive stockings for a period of 6 weeks. Receives: Device: Compressive stockings |
| Control group | No intervention | The control group is treated without compressive stockings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Function KSS 6 weeks postoperative
Knee Society Score - KSS
Measured: 6 weeks postoperative
Knee Function KSS 12 weeks postoperative
Knee Society Score - KSS
Measured: 12 weeks postoperative
Knee Function KSS 1 year postoperative
Knee Society Score - KSS
Measured: 1 year postoperative
Knee Function WOMAC 6 weeks postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Measured: 6 weeks postoperative
Knee Function WOMAC 12 weeks postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Measured: 12 weeks postoperative
Knee Function WOMAC 1 year postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Measured: 1 year postoperative
Pain 6 weeks postoperative
Visuelle Analogskala - VAS (1-10)
Measured: 6 weeks postoperative
Pain 12 weeks postoperative
Visuelle Analogskala - VAS (1-10)
Measured: 12 weeks postoperative
Pain 1 year postoperative
Visuelle Analogskala - VAS (1-10)
Measured: 1 year postoperative
Secondary outcomes (4)
Swelling 6 weeks postoperative
Swelling in mm
Measured: 6 weeks postoperative
Swelling 12 weeks postoperative
Swelling in mm
Measured: 12 weeks postoperative
Swelling 1 year postoperative
Swelling in mm
Measured: 1 year postoperative
Compliance first 6 weeks postoperativ
Measured with Orthotimer sensor
Measured: First 6 weeks postoperativ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Feb 2019
- Primary completion30 May 2022
- Study completion30 May 2022
Why it stopped: not enough study participants and missing compliance to perform analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance of Wearing of Compressive StockingsStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434222
- Sponsor's protocol ID
- W759
- Status last verified
- Jun 2022
- First submitted
- 28 Apr 2020
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Compliance Controlled Postoperative Compressive Stockings Therapy After Total Knee Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04434222
- Acronym / sponsor ID
- W759
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough study participants and missing compliance to perform analysis
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 16 Jun 2020 (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.
Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative swelling and pain and furthermore improve mobilization and knee function.
In this randomized controlled trial, 88 patients are randomized in two groups. One group receives postoperatively compressive stockings for a period of 6 weeks. The control group is treated without compressive stockings. The patients compressive stockings wearing compliance is controlled with a temperature sensitive sensor. The patients will be informed about the implantation of the sensor.
Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score preoperatively and at 12 weeks, 12 months and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compressive stockings group | Active comparator | Device: Compressive stockingsGroup receives postoperatively compressive stockings for a period of 6 weeks. |
| Control group | No intervention | –The control group is treated without compressive stockings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving a total knee replacement
- Written consent of the study participant
Key exclusion criteria (8 listed)
- Peripheral arterial disease II, III or IV
- Diabetes mellitus
- Systemic inflammatory diseases
- Benign or malignant neoplasms
- Revision interventions
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 |
|---|---|---|
| Compressive stockingsCompressive stockings with built in Orthotimer Sensor | Device | Compressive stockings group |
Primary outcome
Knee Function KSS 6 weeks postoperative
Time frame: 6 weeks postoperative
Knee Society Score - KSS
Knee Function KSS 12 weeks postoperative
Time frame: 12 weeks postoperative
Knee Society Score - KSS
Knee Function KSS 1 year postoperative
Time frame: 1 year postoperative
Knee Society Score - KSS
Knee Function WOMAC 6 weeks postoperative
Time frame: 6 weeks postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Knee Function WOMAC 12 weeks postoperative
Time frame: 12 weeks postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Knee Function WOMAC 1 year postoperative
Time frame: 1 year postoperative
Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Pain 6 weeks postoperative
Time frame: 6 weeks postoperative
Visuelle Analogskala - VAS (1-10)
Pain 12 weeks postoperative
Time frame: 12 weeks postoperative
Visuelle Analogskala - VAS (1-10)
Pain 1 year postoperative
Time frame: 1 year postoperative
Visuelle Analogskala - VAS (1-10)
4 secondary outcomes
Swelling 6 weeks postoperative
Time frame: 6 weeks postoperative
Swelling 12 weeks postoperative
Time frame: 12 weeks postoperative
Swelling 1 year postoperative
Time frame: 1 year postoperative
Compliance first 6 weeks postoperativ
Time frame: First 6 weeks postoperativ
Results and safety
The study was stopped early (reason given: not enough study participants and missing compliance to perform analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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 Compressive stockings in people with Compliance of Wearing of Compressive Stockings and Total Knee Arthroplasty, run by Balgrist University Hospital at 1 site in Switzerland.
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 2 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: stopped early, as of the sponsor's last update on 27 Jun 2022. 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 Switzerland. 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 was stopped early (reason given: not enough study participants and missing compliance to perform analysis). Results are not available in the source record.
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?
Knee Function KSS 6 weeks postoperative (time frame: 6 weeks postoperative). The study lists 9 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 Jun 2022.