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

NCT ID: NCT04732884

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2027-01-31

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.

Conditions

Complication of Surgical or Medical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Weight sensor with biofeedback

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

Group Type: EXPERIMENTAL

Smartsens, Gelenic AG; with biofeedback

Intervention Type: DEVICE

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.

Weight sensor without biofeedback

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

Group Type: EXPERIMENTAL

Smartsens, Gelenic AG; without biofeedback

Intervention Type: DEVICE

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

Interventions

Smartsens, Gelenic AG; with biofeedback

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.

Intervention Type: DEVICE

Smartsens, Gelenic AG; without biofeedback

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

Intervention Type: DEVICE

Other Intervention Names

Weight sensor with biofeedback; Weight sensor without biofeedback

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. med. Arno Frigg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Arno Frigg

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

FussZentrumHirslanen

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

BioPed

Identifier Type: -

Identifier Source: org_study_id