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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Zürich, Schweiz, 8008
- Universtiy Hospital Balgrist
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Compressive Stockings group
Patients with compressive stockings at the operated foot for 4 weeks
|
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. |
|
Ingen indgriben: No compressive stockings group
Patients with no compressive stockings at the operated foot
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Wearing Compliance
Tidsramme: 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.
|
6 weeks postoperatively
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain
Tidsramme: 12 weeks postoperatively
|
Pain assessed in a visual analog scale ranging from 0-10 (0= no pain, 10= worst pain)
|
12 weeks postoperatively
|
|
worker´s compensation
Tidsramme: 12 weeks postoperatively
|
% of ability to work the peroperative performed occupation.
|
12 weeks postoperatively
|
|
pain killer use
Tidsramme: 12 weeks postoperatively
|
How many pills per day the patients require for the pain after surgery.
|
12 weeks postoperatively
|
|
AOFAS
Tidsramme: 12 weeks postoperatively
|
American Orthopedic Foot and Ankle Score
|
12 weeks postoperatively
|
|
Swelling
Tidsramme: 12 weeks postoperatively
|
Foot and ankle swelling measured in cm at defined Areas of the foot and ankle
|
12 weeks postoperatively
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Stephan Wirth, Dr. med., Balgrist University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- W568
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Disorder of Ankle Joint
-
University of FaisalabadIkke rekrutterer endnuLedsygdomme | Joint Range of Motion | Posterior Capsule TightnessPakistan