- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02792907
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Zürich, Schweiz, 8008
- Universtiy Hospital Balgrist
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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. |
Inget ingripande: No compressive stockings group
Patients with no compressive stockings at the operated foot
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Wearing Compliance
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain
Tidsram: 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
Tidsram: 12 weeks postoperatively
|
% of ability to work the peroperative performed occupation.
|
12 weeks postoperatively
|
pain killer use
Tidsram: 12 weeks postoperatively
|
How many pills per day the patients require for the pain after surgery.
|
12 weeks postoperatively
|
AOFAS
Tidsram: 12 weeks postoperatively
|
American Orthopedic Foot and Ankle Score
|
12 weeks postoperatively
|
Swelling
Tidsram: 12 weeks postoperatively
|
Foot and ankle swelling measured in cm at defined Areas of the foot and ankle
|
12 weeks postoperatively
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Stephan Wirth, Dr. med., Balgrist University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- W568
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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