Disorder of Ankle JointSENSCOMPNCT02792907
Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings
A study testing Compressive stocking in people with Disorder of Ankle Joint, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Compressive stockings ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery. In this randomized controlled trial the investigators want to analyze the effect of compressive stockings after foot and ankle surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Disorder of Ankle Joint
- What is being tested?
- Compressive stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Jan 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients with a signed informed consent
- all patients, who underwent hindfoot and middlefoot surgery
Who cannot join
- patients with a externe Fixateur.
- patients with contraindication for the use of compressive stockings
- patients with severe General disease (cancer, rheumatoider Arthritis)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universtiy Hospital Balgrist
Zurich, Canton of Zurich, 8008
About this study
Official title: "Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings Treatment in Patients After Elective Foot and Ankle Surgery" A Prospective, Randomized and Controlled Cohort Study
Compressive stockings ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery. In this randomized controlled trial the investigators want to analyze the effect of compressive stockings after foot and ankle surgery. Additionally the investigators want to evaluate the compliance of the compressive stockings Treatment. Therefore an electronic chip device is implanted into the compressive stockings to monitor wearing time.
Read the detailed description
Pain and swelling are typical sequelae following surgical procedures at the foot and ankle. While it is known that compressive stockings treatment decreases swelling and improves overall ankle function and quality of life in patients after ankle fracture, the investigators hypothesize that compressive stockings could also ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery.
Reduced compliance in wearing compressive stockings after foot and ankle surgery might probably be a limiting factor of this postoperative adjuvant compressive therapy. Therefore the investigators want to evaluate patient´s compliance by using an electronic chip device to monitor wearing behavior.
All patients who will be operated on their feet and ankle are randomized and blindly assigned into either the compressive or control-group. Each group consists of 80 patients (160 patients in total). The compression group includes patients who receive postoperative compression stockings. The control group does not receive any stockings. Regular checks at 6 weeks and 12 weeks postoperatively will be performed in order to assess the following parameters:
- Foot and Ankle Scores
- Pain
- Swelling of the foot and lower limb 3. Wearing compliance by electronically recorded wearing time.
The Information about the implanted sensor, which records the stockings wearing time will be given to the patients after the compressive stockings therapy (6 weeks), so that the patients are not influenced by the fact, that their wearing behaviour had been measured.
After this information, the patients decide if the sensor information may be evaluated by the study team or not.
- Conditions
- Disorder of Ankle Joint
- Being tested
- Compressive stocking
- Keywords
- Foot Surgery, Compliance, Compressive Stockings
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressive stockingDevice
After hindfoot and middlefoot surgery the patients from the Intervention Group will be treated with compressive stockings the removal of the suture. That means from the end of week 2 until the end of week 6 after surgery.
Additionally the patients wearing behaviour is monitored by a electronic sensor, which is implanted in the patient´s stocking.
| Study group | Role | What they receive |
|---|---|---|
| Compressive Stockings group | Experimental | Patients with compressive stockings at the operated foot for 4 weeks Receives: Device: Compressive stocking |
| No compressive stockings group | No intervention | Patients with no compressive stockings at the operated foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearing Compliance
With a sensor the wearing time in hours/day is monitored. Patients will be informed about the sensor at the 6 week follow up. They will be asked if the study Team is allowed to read the monitored wearing time.
Measured: 6 weeks postoperatively
Secondary outcomes (5)
Pain
Pain assessed in a visual analog scale ranging from 0-10 (0= no pain, 10= worst pain)
Measured: 12 weeks postoperatively
worker´s compensation
% of ability to work the peroperative performed occupation.
Measured: 12 weeks postoperatively
pain killer use
How many pills per day the patients require for the pain after surgery.
Measured: 12 weeks postoperatively
AOFAS
American Orthopedic Foot and Ankle Score
Measured: 12 weeks postoperatively
Swelling
Foot and ankle swelling measured in cm at defined Areas of the foot and ankle
Measured: 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Ankle JointStudies 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
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Wirth, Dr. med., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792907
- Sponsor's protocol ID
- W568
- Acronym
- SENSCOMP
- Status last verified
- Feb 2017
- First submitted
- 25 May 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings Treatment in Patients After Elective Foot and Ankle Surgery" A Prospective, Randomized and Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT02792907
- Acronym / sponsor ID
- SENSCOMP / W568
- Conditions
- Disorder of Ankle Joint
- Keywords
- Foot Surgery, Compliance, Compressive Stockings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Jun 2016 (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.
Compressive stockings ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery. In this randomized controlled trial the investigators want to analyze the effect of compressive stockings after foot and ankle surgery. Additionally the investigators want to evaluate the compliance of the compressive stockings Treatment. Therefore an electronic chip device is implanted into the compressive stockings to monitor wearing time.
Detailed description
Pain and swelling are typical sequelae following surgical procedures at the foot and ankle. While it is known that compressive stockings treatment decreases swelling and improves overall ankle function and quality of life in patients after ankle fracture, the investigators hypothesize that compressive stockings could also ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery.
Reduced compliance in wearing compressive stockings after foot and ankle surgery might probably be a limiting factor of this postoperative adjuvant compressive therapy. Therefore the investigators want to evaluate patient´s compliance by using an electronic chip device to monitor wearing behavior.
All patients who will be operated on their feet and ankle are randomized and blindly assigned into either the compressive or control-group. Each group consists of 80 patients (160 patients in total). The compression group includes patients who receive postoperative compression stockings. The control group does not receive any stockings. Regular checks at 6 weeks and 12 weeks postoperatively will be performed in order to assess the following parameters:
- Foot and Ankle Scores
- Pain
- Swelling of the foot and lower limb 3. Wearing compliance by electronically recorded wearing time.
The Information about the implanted sensor, which records the stockings wearing time will be given to the patients after the compressive stockings therapy (6 weeks), so that the patients are not influenced by the fact, that their wearing behaviour had been measured.
After this information, the patients decide if the sensor information may be evaluated by the study team or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compressive Stockings group | Experimental | Device: Compressive stockingPatients with compressive stockings at the operated foot for 4 weeks |
| No compressive stockings group | No intervention | –Patients with no compressive stockings at the operated foot |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- all patients with a signed informed consent
- all patients, who underwent hindfoot and middlefoot surgery
Key exclusion criteria (3 listed)
- patients with a externe Fixateur.
- patients with contraindication for the use of compressive stockings
- patients with severe General disease (cancer, rheumatoider Arthritis)
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 stockingAfter hindfoot and middlefoot surgery the patients from the Intervention Group will be treated with compressive stockings the removal of the suture. That means from the end of week 2 until the end of week 6 after surgery. Additionally the patients wearing behaviour is monitored by a electronic sensor, which is implanted in the patient´s stocking. | Device | Compressive Stockings group |
Primary outcome
Wearing Compliance
Time frame: 6 weeks postoperatively
With a sensor the wearing time in hours/day is monitored. Patients will be informed about the sensor at the 6 week follow up. They will be asked if the study Team is allowed to read the monitored wearing time.
5 secondary outcomes
Pain
Time frame: 12 weeks postoperatively
worker´s compensation
Time frame: 12 weeks postoperatively
pain killer use
Time frame: 12 weeks postoperatively
AOFAS
Time frame: 12 weeks postoperatively
Swelling
Time frame: 12 weeks postoperatively
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 14 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Stephan Wirth, Dr. med. principal investigator
Balgrist University Hospital
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 stocking in people with Disorder of Ankle Joint, 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 3 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 14 Feb 2017. 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 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?
Wearing Compliance (time frame: 6 weeks postoperatively). 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 14 Feb 2017.