Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings

Disorder of Ankle Joint Clinical Trial

— SENSCOMP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792907
• Other study ID #: W568
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: February 13, 2017
• Start date: July 2016
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Disorder of Ankle Joint

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Universtiy Hospital Balgrist	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

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