Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings (SENSCOMP)
"Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings Treatment in Patients After Elective Foot and Ankle Surgery" A Prospective, Randomized and Controlled Cohort Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
2. 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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Zürich, Zwitserland, 8008
- Universtiy Hospital Balgrist
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion criteria:
- all patients with a signed informed consent
- all patients, who underwent hindfoot and middlefoot surgery
Exclusion criteria:
- patients with a externe Fixateur.
- patients with contraindication for the use of compressive stockings
- patients with severe General disease (cancer, rheumatoider Arthritis)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Compressive Stockings group
Patients with compressive stockings at the operated foot for 4 weeks
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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. |
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Geen tussenkomst: No compressive stockings group
Patients with no compressive stockings at the operated foot
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Wearing Compliance
Tijdsspanne: 6 weeks postoperatively
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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.
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6 weeks postoperatively
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain
Tijdsspanne: 12 weeks postoperatively
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Pain assessed in a visual analog scale ranging from 0-10 (0= no pain, 10= worst pain)
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12 weeks postoperatively
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worker´s compensation
Tijdsspanne: 12 weeks postoperatively
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% of ability to work the peroperative performed occupation.
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12 weeks postoperatively
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pain killer use
Tijdsspanne: 12 weeks postoperatively
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How many pills per day the patients require for the pain after surgery.
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12 weeks postoperatively
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AOFAS
Tijdsspanne: 12 weeks postoperatively
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American Orthopedic Foot and Ankle Score
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12 weeks postoperatively
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Swelling
Tijdsspanne: 12 weeks postoperatively
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Foot and ankle swelling measured in cm at defined Areas of the foot and ankle
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12 weeks postoperatively
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Stephan Wirth, Dr. med., Balgrist University Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- W568
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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