Clinical trial NCT02792907: Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Ankle Joint
Keywords: Foot Surgery
Compliance
Compressive Stockings
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Wearing Compliance
timeFrame: 6 weeks postoperatively
Secondary outcomes:
measure: Pain
timeFrame: 12 weeks postoperatively
measure: worker´s compensation
timeFrame: 12 weeks postoperatively
measure: pain killer use
timeFrame: 12 weeks postoperatively
measure: AOFAS
timeFrame: 12 weeks postoperatively
measure: Swelling
timeFrame: 12 weeks postoperatively
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universtiy Hospital Balgrist
Study officials:
affiliation: Balgrist University Hospital
name: Stephan Wirth, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: