Osteochondral Lesion of TalusNCT04194970
Monitoring of Weight Bearing Protocols Via Mobile Application and Pressure Sensors.
A study testing With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations in people with Osteochondral Lesion of Talus, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Randomized, prospective, double-blind study: Avascular, anöral and non-regenerative cartilage tissue mostly repaired via arthroscopic surgeries. After that, the patients rehabilitate with optimum weight bearing protocols in post-operative and discharge periods by physiotherapists. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteochondral Lesion of Talus
- What is being tested?
- With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 10 Aug 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a symptomatic osteochondral lesion of the Talus.
- Magnetic resonance of the ankle showing osteochondral injury of a single talus
- People who can use smart phone (andoid or ios)
Who cannot join
- Recurrent osteochondral lesions of the talus
- Multiple osteochondral lesions
- Severe ankle instability, requiring open repair
- History of a previous foot or ankle surgery of the ipsilateral foot
- Having a systematic disorders like Diabetes Mellitus, Rheumatoid arthritis etc.
- Inability to return to the surgery site to practice long-term follow-up evaluations or lack of readiness to complete the indicated evaluation forms.
- Patients with a qualitative or quantitative commitment that prevents consent or assent their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Monitoring Weight Bearing Protocols Following Lower Extremity Surgeries Via Mobile Application and Pressure Sensors.
Randomized, prospective, double-blind study: Avascular, anöral and non-regenerative cartilage tissue mostly repaired via arthroscopic surgeries. After that, the patients rehabilitate with optimum weight bearing protocols in post-operative and discharge periods by physiotherapists. In the post-operative period, optimum weight bearing is vital for this tissue healing. There is not any opportunity or device to follow up the compliance of patients to weight bearing. We aimed to develop a device with mobile application to monitor the compliance the patients to weight bearing protocols. This device is designed to could give negative live feedback (with visual audible and vibrating warnings) in order to ensure the compliance of patients. Thanks to the device, health professionals will also have the opportunity to monitor the patient's compliance with the protocol on a daily basis. We hypothesized that patients monitored with this device may have a better recovery.
Read the detailed description
The cartilage tissue, reduces the friction forces in the joints and distributes loads on the joints, is damaged by aging, trauma exposure and degeneration. This tissue is avascular, aneural and non-regenerative. To repair the damaged cartilage tissue arthroplasty method is mostly chosen and the surgery of talus osteochondral lesions is mostly performed type among them. In the post-operative period, optimum weight bearing is vital for this tissue healing. Optimum weight bearing means that the repaired tissue is loaded by a weight which is in between specific percentage of the body weight. During the healing process, educating and compliance of the patients about optimum weight bearing in hospital and after discharge it is difficult to ensure continuity of compliance. At that point the clinical problem arises in terms of teaching the patients the preferred weight bearing percentages (protocols) and their compliance on weight bearing protocols both in hospitalization and home care period. There is not any opportunity or device to follow up the compliance of patients to weight bearing protocols after discharge. A research stated that as the pain symptom decreases, the compliance of patients to optimum weight bearing protocols disappear in home care period even if they had adhered the taught protocol at the clinic. The loss of compliance in the postoperative rehabilitation phase can delay repaired tissue healing and often revision surgery be necessary. This situation necessitated the follow-up of the patients by the physiotherapist using the live-feedback systems. For this purpose, we aimed to develop an android mobile application (system) that will work synchronized with pressure sensors placed under an insole (device). The producing and effectiveness research of mentioned device will consist of two stages. At the first stage will be about product development and testing with volunteer healthy participants. At the second stage named as testing its applicability on patients. The patients will be randomized to two group as Group I (rehabilitate with live-feedback system) and Group II (rehabilitate via system without live- feedback) to evaluate the effectiveness of the live-feedback and mentioned system. The volunteer patients will be evaluated each day, in term of compliance with the weight bearing protocol for 6 weeks. The American Orthopedic Foot Ankle Society, Ankle-hindfoot (AOFAS-AHF) scoring will be administered to each patient on preoperative day and 6 weeks after surgery in order to be evaluate assess the effectiveness of clinical recovery. We expect, thanks to this live feedback system, the health professionals to be capable of determining and monitoring of patients' weight bearing percentages to the body weight during their healing process. Also, the patient will be alerted by the system with visual audible and vibrating warnings, if non-compliance with the weight bearing protocol. Thus, patients can do their own follow-up without a health professional. In this way, continuity of compliance could be ensured. We hypothesized that the development of the insole is expected to help overcome the clinical difficulties encountered during the rehabilitation process and reduce the need for revision operations.
- Conditions
- Osteochondral Lesion of Talus
- Being tested
- With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations
- Keywords
- Weight bearing monitoring,, Live-biofeedback, Lower extremity, Rehabilitation, WBM smart insole system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situationsDevice
Weight Bearing Protocol (Duration: Post-Op. 6 week)
- Post-op 3 week non-weight bearing (%0 body weight of patient)
- Post- op 3 week touch down weight bearing (%10-%20 body weight of patient) Group I - monitoring with device while the live feedback mechanism turned on Group II- monitoring with device while the live feedback mechanism turned off
| Study group | Role | What they receive |
|---|---|---|
| Group I (monitoring with live-feedback system) | Experimental | WBM smart insole system is a product that can monitor the pressure under the foot and provide live feedback (if this option activated) to the user in case of exceeding the specified limits. Its components are insole with pressure sensors and mobile applications (IOS, Android). Post-operative patients (osteochondral lesion of the talus) will be monitored with the WBM smart insole system in case live feedback is turned on. We aimed to ensure the compliance of patients to specified weight bearing limits. We will follow up this grup for 6 weeks periods with WBM smart insole system. Pre-op. and post-op 6 week, we evaluate the patients in case of ankle function, pain with The American Orthopaedic Foot \& Ankle Society (AOFAS) Scoring. Also we will monitor the compliance success of patients with WBM smart insole system during 6 week. The relationship with compliance to weight bearing success and AOFAS scores will be evaluate. Receives: Device: With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations |
| Group II (monitoring without live feedback) | Active comparator | The post-operative patients (osteochondral lesion of talus), follow-up with product in live-feedback closed condition.
After surgery, we will educate the patients about weight bearing protocol on post-op first day and post op 3 week. The protocol is " first 3 weeks, %0 body weight bearing (BWB), second 3 weeks between %10-%20 BWB". Patients' compliance to BWB protocol will be monitored daily with the WBM smart insole system in case live-feedback is turned off. Pre-op and post-op 6 week, we evaluate the patients in case of ankle function, pain with The American Orthopaedic Foot \& Ankle Society (AOFAS) Scoring. The relationship with compliance to weight bearing success and AOFAS scores will be evaluate. Receives: Device: With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the clinical recovery of osteochondral lesion of talus post operative patients.
American Orthopedic Foot and Ankle Society- Ankle hindfoot scale will be used for this evaluation. The scale includes nine items that can be divided into three sub-scales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. This scale will be used for evaluation the clinical recovery of osteochondral lesion of talus post operative patients.
Measured: pre-operative day, post-op 6 week, post-op 12 week, post-op 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2022
- Primary completion30 May 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First Step of Research: development of product that can provide live-feedback (insole with pressure sensors, mobile application) (approximately- 10 healthy volunteers) Second Step of Research: Testing this product on healthy volunteers Third Step of Research: Following up the post-operative patients with product ( Group I - monitoring with live feedback, Group II- monitoring without live-feedback) (approximately- 10 post-operative patients)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ender Ersin Avci, Marmara University
- Investigators
- İlkşan Demirbüken, Assoc.Prof., Study chair, Marmara UniversityEnder Ersin AVCI, MsC, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194970
- Sponsor's protocol ID
- 09.2019.593
- Status last verified
- Aug 2022
- First submitted
- 28 Nov 2019
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Monitoring Weight Bearing Protocols Following Lower Extremity Surgeries Via Mobile Application and Pressure Sensors.
- ClinicalTrials.gov ID
- NCT04194970
- Acronym / sponsor ID
- 09.2019.593
- Conditions
- Osteochondral Lesion of Talus
- Keywords
- Weight bearing monitoring,, Live-biofeedback, Lower extremity, Rehabilitation, WBM smart insole system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 11 Dec 2019 (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.
Randomized, prospective, double-blind study: Avascular, anöral and non-regenerative cartilage tissue mostly repaired via arthroscopic surgeries. After that, the patients rehabilitate with optimum weight bearing protocols in post-operative and discharge periods by physiotherapists. In the post-operative period, optimum weight bearing is vital for this tissue healing. There is not any opportunity or device to follow up the compliance of patients to weight bearing. We aimed to develop a device with mobile application to monitor the compliance the patients to weight bearing protocols. This device is designed to could give negative live feedback (with visual audible and vibrating warnings) in order to ensure the compliance of patients. Thanks to the device, health professionals will also have the opportunity to monitor the patient's compliance with the protocol on a daily basis. We hypothesized that patients monitored with this device may have a better recovery.
Detailed description
The cartilage tissue, reduces the friction forces in the joints and distributes loads on the joints, is damaged by aging, trauma exposure and degeneration. This tissue is avascular, aneural and non-regenerative. To repair the damaged cartilage tissue arthroplasty method is mostly chosen and the surgery of talus osteochondral lesions is mostly performed type among them. In the post-operative period, optimum weight bearing is vital for this tissue healing. Optimum weight bearing means that the repaired tissue is loaded by a weight which is in between specific percentage of the body weight. During the healing process, educating and compliance of the patients about optimum weight bearing in hospital and after discharge it is difficult to ensure continuity of compliance. At that point the clinical problem arises in terms of teaching the patients the preferred weight bearing percentages (protocols) and their compliance on weight bearing protocols both in hospitalization and home care period. There is not any opportunity or device to follow up the compliance of patients to weight bearing protocols after discharge. A research stated that as the pain symptom decreases, the compliance of patients to optimum weight bearing protocols disappear in home care period even if they had adhered the taught protocol at the clinic. The loss of compliance in the postoperative rehabilitation phase can delay repaired tissue healing and often revision surgery be necessary. This situation necessitated the follow-up of the patients by the physiotherapist using the live-feedback systems. For this purpose, we aimed to develop an android mobile application (system) that will work synchronized with pressure sensors placed under an insole (device). The producing and effectiveness research of mentioned device will consist of two stages. At the first stage will be about product development and testing with volunteer healthy participants. At the second stage named as testing its applicability on patients. The patients will be randomized to two group as Group I (rehabilitate with live-feedback system) and Group II (rehabilitate via system without live- feedback) to evaluate the effectiveness of the live-feedback and mentioned system. The volunteer patients will be evaluated each day, in term of compliance with the weight bearing protocol for 6 weeks. The American Orthopedic Foot Ankle Society, Ankle-hindfoot (AOFAS-AHF) scoring will be administered to each patient on preoperative day and 6 weeks after surgery in order to be evaluate assess the effectiveness of clinical recovery. We expect, thanks to this live feedback system, the health professionals to be capable of determining and monitoring of patients' weight bearing percentages to the body weight during their healing process. Also, the patient will be alerted by the system with visual audible and vibrating warnings, if non-compliance with the weight bearing protocol. Thus, patients can do their own follow-up without a health professional. In this way, continuity of compliance could be ensured. We hypothesized that the development of the insole is expected to help overcome the clinical difficulties encountered during the rehabilitation process and reduce the need for revision operations.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- First Step of Research: development of product that can provide live-feedback (insole with pressure sensors, mobile application) (approximately- 10 healthy volunteers) Second Step of Research: Testing this product on healthy volunteers Third Step of Research: Following up the post-operative patients with product ( Group I - monitoring with live feedback, Group II- monitoring without live-feedback) (approximately- 10 post-operative patients)
| Arm | Type | Receives |
|---|---|---|
| Group I (monitoring with live-feedback system) | Experimental | Device: With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situationsWBM smart insole system is a product that can monitor the pressure under the foot and provide live feedback (if this option activated) to the user in case of exceeding the specified limits. Its components are insole with pressure sensors and mobile applications (IOS, Android). Post-operative patients (osteochondral lesion of the talus) will be monitored with the WBM smart insole system in case live feedback is turned on. We aimed to ensure the compliance of patients to specified weight bearing limits. We will follow up this grup for 6 weeks periods with WBM smart insole system. Pre-op. and post-op 6 week, we evaluate the patients in case of ankle function, pain with The American Orthopaedic Foot \& Ankle Society (AOFAS) Scoring. Also we will monitor the compliance success of patients with WBM smart insole system during 6 week. The relationship with compliance to weight bearing success and AOFAS scores will be evaluate. |
| Group II (monitoring without live feedback) | Active comparator | Device: With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situationsThe post-operative patients (osteochondral lesion of talus), follow-up with product in live-feedback closed condition. After surgery, we will educate the patients about weight bearing protocol on post-op first day and post op 3 week. The protocol is " first 3 weeks, %0 body weight bearing (BWB), second 3 weeks between %10-%20 BWB". Patients' compliance to BWB protocol will be monitored daily with the WBM smart insole system in case live-feedback is turned off. Pre-op and post-op 6 week, we evaluate the patients in case of ankle function, pain with The American Orthopaedic Foot \& Ankle Society (AOFAS) Scoring. The relationship with compliance to weight bearing success and AOFAS scores will be evaluate. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a symptomatic osteochondral lesion of the Talus.
- Magnetic resonance of the ankle showing osteochondral injury of a single talus
- People who can use smart phone (andoid or ios)
Key exclusion criteria (7 listed)
- Recurrent osteochondral lesions of the talus
- Multiple osteochondral lesions
- Severe ankle instability, requiring open repair
- History of a previous foot or ankle surgery of the ipsilateral foot
- Having a systematic disorders like Diabetes Mellitus, Rheumatoid arthritis etc.
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 |
|---|---|---|
| With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situationsWeight Bearing Protocol (Duration: Post-Op. 6 week) * Post-op 3 week non-weight bearing (%0 body weight of patient) * Post- op 3 week touch down weight bearing (%10-%20 body weight of patient) Group I - monitoring with device while the live feedback mechanism turned on Group II- monitoring with device while the live feedback mechanism turned off | Device | Group I (monitoring with live-feedback system), Group II (monitoring without live feedback) |
Primary outcome
Evaluation the clinical recovery of osteochondral lesion of talus post operative patients.
Time frame: pre-operative day, post-op 6 week, post-op 12 week, post-op 24 week
American Orthopedic Foot and Ankle Society- Ankle hindfoot scale will be used for this evaluation. The scale includes nine items that can be divided into three sub-scales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. This scale will be used for evaluation the clinical recovery of osteochondral lesion of talus post operative patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- 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.
İlkşan Demirbüken, Assoc.Prof. study chair
Marmara University
Ender Ersin AVCI, MsC principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With WBM smart insole system to monitor compliance of specified weight bearing limits data in live feedback on and off situations in people with Osteochondral Lesion of Talus, run by Marmara University at 1 site in Turkey (Türkiye).
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 7 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: finished, as of the sponsor's last update on 19 Aug 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the clinical recovery of osteochondral lesion of talus post operative patients. (time frame: pre-operative day, post-op 6 week, post-op 12 week, post-op 24 week). 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 19 Aug 2022.