Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings

NCT ID: NCT02792907

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-01-31

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.

Conditions

Disorder of Ankle Joint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Compressive Stockings group

Patients with compressive stockings at the operated foot for 4 weeks

Group Type: EXPERIMENTAL

Compressive stocking

Intervention Type: DEVICE

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.

No compressive stockings group

Patients with no compressive stockings at the operated foot

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Compressive stocking

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.

Intervention Type: DEVICE

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Balgrist University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Wirth, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Balgrist University Hospital

Locations

Universtiy Hospital Balgrist

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

W568

Identifier Type: -

Identifier Source: org_study_id