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

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Ankle Joint
• Intervention / Treatment: Device: Compressive stocking

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Universtiy Hospital Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compressive Stockings group; Patients with compressive stockings at the operated foot for 4 weeks	Device: 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.
No Intervention: No compressive stockings group; Patients with no compressive stockings at the operated foot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearing Compliance	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain assessed in a visual analog scale ranging from 0-10 (0= no pain, 10= worst pain)	12 weeks postoperatively
worker´s compensation	% of ability to work the peroperative performed occupation.	12 weeks postoperatively
pain killer use	How many pills per day the patients require for the pain after surgery.	12 weeks postoperatively
AOFAS	American Orthopedic Foot and Ankle Score	12 weeks postoperatively
Swelling	Foot and ankle swelling measured in cm at defined Areas of the foot and ankle	12 weeks postoperatively

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Stephan Wirth, Dr. med., Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Compliance; Foot Surgery; Compressive Stockings
• Other Study ID Numbers: W568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO