Evaluation of the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis

Prof. Dr. med. Arno Frigg216 enrolled

Overview

The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback.

Post-traumatic situations or instabilities of other aetiology at the level of the foot can lead to painful degenerative arthritis that necessitates surgical arthrodesis for pain relief. Surgical arthrodesis in this region though is associated with a high risk of osseous non-union (depending on the exact location up to 40%) despite standardized preparation and fixation techniques. The development of osseous non-union is associated with certain patient characteristics like active smoking, nutrition etc. Compliance to partial weight-bearing during the early postoperative phase is another contributing factor. The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback. All patients will postoperatively be provided with a lower- leg unloading orthosis furnished with a weight sensor that will - according to randomization - give feedback if a predefined weight threshold has been crossed or just measure weight-bearing without feedback.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

216

Conditions

Complication of Surgical or Medical Care

Interventions

Smartsens, Gelenic AG; with biofeedbackDEVICE

The Smartsens is a CE certified 4-cell load sensor integrated in an insole that can be placed in any orthosis or cast. A threshold (10-50kg) can be defined at which - if higher loads are measured - an audio signal warns the patient of overloading (biofeedback). The device additionally registers loads from 0-100kg continuously.

Smartsens, Gelenic AG; without biofeedbackDEVICE

Patients will not be warned by an audio signal in case of overloading. The device registers loads from 0-100kg continuously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Indication for hind- or midfoot arthrodesis * Informed Consent * Body weight \< 90kg (according to Smartsens manufacturers recommendations) Exclusion Criteria: * Physical or mental inability to follow weight-bearing recommendations (e.g. dementia, neurologic disease, upper extremity pathology) * Participation in a potentially interfering interventional trial during the last 30 day or before wash-out of any trial medication (e.g. steroids, medications affecting bone metabolism etc.) * Previous infection at the intended surgical site * Body weight \> 90kg * Pregnancy

Locations (1)

FussZentrumHirslanen

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Evaluation of the influence of weight bearing an resting time on the development of osseous non-union after surgical arthrodesis at the level of the mid- and hindfoot.

The primary outcome is an analysis of the rate of non-unions after mid- and hindfoot arthrodesis comparing a sensor the two patient arms with activated vs non-activated biofeedback. The rate of osseous non-unions defined as CT-morphologic union \<30% of the joint surface at 3 months in relation to the provision of biofeedback.

Time frame: 3 months

Secondary Outcomes

Compliance i.e. adherence to weight bearing recommendations (≤ 15kg charge) with and without biofeedback.

All patients will be asked to wear the orthosis with integrated sensor all day long including resting times. They are furthermore instructed to follow partial weight-bearing with 15kg (for 6 weeks). The device will record load and quantity of steps over time. In the first group, a biofeedback in form of an audio-signal will warn the patient if treatment recommendations like partial weight bearing are not followed. The control intervention will be pure instruction followed by measurements. Control patients will not receive biofeedback upon transgression of recommendations.

Time frame: 6 weeks

Compliance i.e. adherence to resting time recommendations (≥ 80% of time) with and without biofeedback.

All patients will be asked to wear the orthosis with integrated sensor all day long including resting times. They are furthermore instructed to reduce their activity with 80% resting time. The device will record load and quantity of steps over time. In the first group, a biofeedback in form of an audio-signal will warn the patient if treatment recommendations like resting times are not followed. The control intervention will be pure instruction followed by measurements of load and quantity of steps. Control patients will not receive biofeedback upon transgression of recommendations.

Time frame: 6 weeks

Consumption of analgesic medication after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.