Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings (SENSCOMP)

Balgrist University Hospital

Status: Completed

Conditions: Disorder of Ankle Joint

Treatments: Device: Compressive stocking

Study type: Interventional

Funder types: Other

Identifiers

NCT02792907

W568

Details and patient eligibility

About

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.

Full 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

3. 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.

Enrollment: 100 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Compressive Stockings group

Experimental group

Description:

Patients with compressive stockings at the operated foot for 4 weeks

Treatment:

Device: Compressive stocking

No compressive stockings group

No Intervention group

Description:

Patients with no compressive stockings at the operated foot