Clinical trial NCT04732884: Evaluation of the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis
Official title: A Prospective Randomized Controlled Monocentric Trial Evaluating the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Complication of Surgical or Medical Care
Keywords: mid- and hindfoot surgical arthrodesis
osseous non-union
Lead sponsor: Klinik Hirslanden, Zurich
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, prospective, randomized, controlled trial
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: Compliance i.e. adherence to weight bearing recommendations (≤ 15kg charge) with and without biofeedback.
timeFrame: 6 weeks
measure: Compliance i.e. adherence to resting time recommendations (≥ 80% of time) with and without biofeedback.
timeFrame: 6 weeks
measure: Consumption of analgesic medication after surgery
timeFrame: 12 months
measure: Patient's quality of life after surgery
timeFrame: 12 months
measure: Patient's satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: FussZentrumHirslanen
Study officials:
References: