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NCT Number: NCT02792907

Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings

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.

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Key information

Conditions

Disorder of Ankle Joint Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universtiy Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

About this study

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:

  • Foot and Ankle Scores
  • Pain
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Compressive stocking

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.

Primary outcomes

  1. Wearing Compliance

    Time frame: 6 weeks postoperatively

    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.

Secondary outcomes

  1. Pain

    Time frame: 12 weeks postoperatively

    Pain assessed in a visual analog scale ranging from 0-10 (0= no pain, 10= worst pain)

  2. worker´s compensation

    Time frame: 12 weeks postoperatively

    % of ability to work the peroperative performed occupation.

  3. pain killer use

    Time frame: 12 weeks postoperatively

    How many pills per day the patients require for the pain after surgery.

  4. AOFAS

    Time frame: 12 weeks postoperatively

    American Orthopedic Foot and Ankle Score

  5. Swelling

    Time frame: 12 weeks postoperatively

    Foot and ankle swelling measured in cm at defined Areas of the foot and ankle

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study 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

Acronym: SENSCOMP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2016
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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