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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Zürich, Sveits, 8008
- Universtiy Hospital Balgrist
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: No compressive stockings group
Patients with no compressive stockings at the operated foot
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Wearing Compliance
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Stephan Wirth, Dr. med., Balgrist University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- W568
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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