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

Prof. Dr. med. Arno Frigg

Status: Suspended

Conditions: Complication of Surgical or Medical Care

Treatments: Device: Smartsens, Gelenic AG; with biofeedback; Device: Smartsens, Gelenic AG; without biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04732884

BioPed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Weight sensor with biofeedback

Experimental group

Description:

Activation of the feedback function of the weight-bearing sensor as mean to possibly enhance compliance to weight-bearing instructions postoperative.

Treatment:

Device: Smartsens, Gelenic AG; with biofeedback

Weight sensor without biofeedback

Experimental group

Description:

Standard patient education considering postoperative weight-bearing parameters and measurement of actual weight-bearing with the sensor.

Treatment:

Device: Smartsens, Gelenic AG; without biofeedback