Complication of Surgical or Medical CareNCT04732884
Evaluation of the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis
A study testing Smartsens, Gelenic AG; with biofeedback and Smartsens, Gelenic AG; without biofeedback in people with Complication of Surgical or Medical Care, run by Prof. Dr. med. Arno Frigg at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Surgical or Medical Care
- What is being tested?
- Smartsens, Gelenic AG; with biofeedback and Smartsens, Gelenic AG; without biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for hind- or midfoot arthrodesis
- Informed Consent
- Body weight < 90kg (according to Smartsens manufacturers recommendations)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Monocentric Trial Evaluating the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis
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.
Read the 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
- Being tested
- Smartsens, Gelenic AG; with biofeedback, Smartsens, Gelenic AG; without biofeedback
- Keywords
- mid- and hindfoot surgical arthrodesis, osseous non-union
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartsens, Gelenic AG; with biofeedbackDevice
Also called Weight sensor 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.
Smartsens, Gelenic AG; without biofeedbackDevice
Also called Weight sensor without biofeedback
Patients will not be warned by an audio signal in case of overloading. The device registers loads from 0-100kg continuously.
| Study group | Role | What they receive |
|---|---|---|
| Weight sensor with biofeedback | Experimental | Activation of the feedback function of the weight-bearing sensor as mean to possibly enhance compliance to weight-bearing instructions postoperative. Receives: Device: Smartsens, Gelenic AG; with biofeedback |
| Weight sensor without biofeedback | Experimental | Standard patient education considering postoperative weight-bearing parameters and measurement of actual weight-bearing with the sensor. Receives: Device: Smartsens, Gelenic AG; without biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 6 weeks
Consumption of analgesic medication after surgery
Consumption of analgesic medication following WHO grading. Data will be collected at any scheduled (2 and 6 weeks, 3 and 12 months) or unscheduled follow-up visits.
Measured: 12 months
Patient's quality of life after surgery
Quality of life will be analysed by using EuroQuality of Life Five Dimensions (EQ5D-5L) questionnaire at baseline and after 3 months and 12 months.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: 12 months
Patient's satisfaction
Patient satisfaction will be documented after 2 weeks, 6 weeks, 3 months and 12 months by using net promotor score (NPS).
NPS is the percentage of customers rating their likelihood to recommend the "service" to a friend or colleague as 9 or 10 ("promoters") minus the percentage rating this at 6 or below ("detractors") on a scale from 0 to 10.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start25 Sep 2023
- Primary completionAug 2026 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Trial was suspended for technical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical or Medical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, prospective, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Arno Frigg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Arno Frigg, Klinik Hirslanden, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732884
- Sponsor's protocol ID
- BioPed
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Monocentric Trial Evaluating the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis
- ClinicalTrials.gov ID
- NCT04732884
- Acronym / sponsor ID
- BioPed
- Conditions
- Complication of Surgical or Medical Care
- Keywords
- mid- and hindfoot surgical arthrodesis, osseous non-union
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Trial was suspended for technical reasons
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Arno FriggUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Monocentric, prospective, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Weight sensor with biofeedback | Experimental | Device: Smartsens, Gelenic AG; with biofeedbackActivation of the feedback function of the weight-bearing sensor as mean to possibly enhance compliance to weight-bearing instructions postoperative. |
| Weight sensor without biofeedback | Experimental | Device: Smartsens, Gelenic AG; without biofeedbackStandard patient education considering postoperative weight-bearing parameters and measurement of actual weight-bearing with the sensor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for hind- or midfoot arthrodesis
- Informed Consent
- Body weight < 90kg (according to Smartsens manufacturers recommendations)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartsens, Gelenic AG; with biofeedbackAlso: Weight sensor with biofeedbackThe 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. | Device | Weight sensor with biofeedback |
| Smartsens, Gelenic AG; without biofeedbackAlso: Weight sensor without biofeedbackPatients will not be warned by an audio signal in case of overloading. The device registers loads from 0-100kg continuously. | Device | Weight sensor without biofeedback |
Primary outcome
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.
Time frame: 3 months
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.
5 secondary outcomes
Compliance i.e. adherence to weight bearing recommendations (≤ 15kg charge) with and without biofeedback.
Time frame: 6 weeks
Compliance i.e. adherence to resting time recommendations (≥ 80% of time) with and without biofeedback.
Time frame: 6 weeks
Consumption of analgesic medication after surgery
Time frame: 12 months
Patient's quality of life after surgery
Time frame: 12 months
Patient's satisfaction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartsens, Gelenic AG; with biofeedback and Smartsens, Gelenic AG; without biofeedback in people with Complication of Surgical or Medical Care, run by Prof. Dr. med. Arno Frigg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.