Disorder of Ankle Joint Clinical Trial
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.
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:
1. Foot and Ankle Scores
2. 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.
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