Gait, UnsteadyNCT04268680
Perioperative Case Series: Qualitative Evaluation of Gait Cycle and Ground in Knee Arthroplasty Patients
An observational study of Gait, Unsteady, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Gait analysis is a quick and powerful tool with a wide range of clinical applications in various fields. However, due to the expensive and highly specialized equipment required, gait studies are mostly limited to academic research centers and small sample sizes and no large-scale, randomized controlled trials have… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Gait, Unsteady
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2017to 8 Jun 2018
- Phase
- Observational
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by degenerative gonarthrosis who need a TKA in one of the two Knees
Who may be able to join
- primary TKA
- 45-75 years of age (included)
- skeletally mature
- willing and able to participate in required pre-op and follow-up visits at the investigational site and to complete study procedures and questionnaires
- consented to participating in the study by signing the IRB/EC approved informed consent form
- BMI <32
Who cannot join
- symptomatic/debilitating co-commitant arthropathy of non-operative joints (e.g. a TKA patient cannot have advanced arthritis of the contralateral knee or ipsilateral hip/ankle) that would impede or otherwise confuse the peri-operative measurement of gait.
- Significant comorbidities that would impede the patients ability to participate in standard recovery and rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Case Series: Qualitative Evaluation of Gait Cycle and Ground in Knee
Gait analysis is a quick and powerful tool with a wide range of clinical applications in various fields. However, due to the expensive and highly specialized equipment required, gait studies are mostly limited to academic research centers and small sample sizes and no large-scale, randomized controlled trials have been performed. Several authors have proposed inexpensive accelerometer-based systems to remedy this situation. Through mathematic transformation they adequately measure step time and length. With these systems however only temporal spatial gait parameters can be recorded; kinetic gait parameters, such as ground reaction force, cannot be measured. As these kinetic parameters are important for clinical studies, especially in fracture and rehabilitation research different methods are needed. Its availability is mainly limited to research centers, conventional gait analysis is further hindered by its stationarity and that it only allows momentary views of the patient's gait in a confined research environment. Even smaller, wearable systems have to be attached to an external apparatus, or are limited by their battery capacity, data storage and other device specific factors. Furthermore, the use of these systems is at an early clinical stage and their full potential not yet developed. As most disease processes are continuous, tools with long-term, continuous measuring capabilities are needed. For this reason a new pressure-measuring insole with built in battery and data storage was developed in cooperation with the AO Foundation(AO Foundation, Davos, Switzerland). The system offers complete independence from any external measures for up to 4 weeks and monitors a patient step during this time.
The purpose of this pilot study is to investigate which how TKA arthroplasty may impact gait during early and medium term rehabilitation phase. This will be done through the use of the OpenGo Sensor Insole (Moticon GmbH).
Read the detailed description
Advanced degenerative arthropathies of the knee ultimately manifest as pain and a loss of function leading to impaired gait and activity. Total knee arthroplasty (TKA) is a procedure that aim to eliminate pain, restore the function of the joint and ultimately improve the ability of the patient to move and live an active life. TotalKneeArthroplasty has a history of success, but as the orthopedic and healthcare sectors evolve, a greater level of scrutiny and expectation for success will be applied to surgeons and device makers alike. In response to these elevated levels of scrutiny and expectation more advanced methods will likely be required to better capture and understand how a TotalKneeArthroplasty impacts patient function both on an individual, patient by patient, basis as well as on device design and surgical technique basis.
The present study is aimed at performing a preliminary evaluation to provide:
More advanced insight into a patient's functional recovery and rehabilitation with the potential for phisician's to intervene earlier and with greater specificity to any challenges encountered by the patient Objective evidence of the quality and value of the intervention on an individualized basis. Study objectives Any change in gait as a result of arthroplasty and dynamics of gait recovery during acute recovery and rehabilitation timeframe. Outcome measures will be gait cycle and ground: foot interaction dynamics which will be observed longitudinally and compared to the healthy contralateral limb (ground: foot interaction dynamics) as well literature data (gait cycle).
Primary objective:Evaluation of gait cycle and ground in primary TotalKneeArthroplasty patients compared to the healthy contralateral limb.
Secondary objectives:Easy of use. Qualitative user (Phisician and patient) feedback on experience using and wearing the insoles Study design:This is, single arm, prospective, single center, pilot study to measure the pre-operative and post-operative gait and ground: foot interaction dynamics of 6 subjects who are undergoing TotalKneeArthroplasty .
Data that will be collected at baseline (pre-op) besides the standard clinical data (VisualAnalogueScale, KneeSocietyScore SatisfactionForm-12, Knee Injury and Osteoarthritis Outcome Score(KOOS)) include: gait and ground: foot interaction dynamics during a prescribed in clinic activity as well as during activities of daily living.
Data that will be collected about the clinical follow-up include: gait and ground: foot interaction dynamics during a prescribed in clinic activity as well as during activities of daily living; user feedback regarding their experience using and wearing the insoles.
Total study duration for study participants will be 6 months with follow-up visits planned at: daily until discharge, 1 week, 2 weeks, 3 weeks, 3 months and 6 months. Full enrollement is estimated to require 1 months, therefore the total study duration is expected to be 7 months.
Subjects will be included in 1 Italian site. Data and user feedback will be analyzed continuously as they become available throughout the study period.
Patients selection:Once a subject has completed the informed consent procedure and signed the Informed Consent Form, the PI or delegated study research staff can complete the screening process with the subject. All potential subjects who undergo the screening process will be documented on a Screening and Enrollment Log, on which reasons for exclusion from or denial to participate should be noted.
- Conditions
- Gait, Unsteady
- Keywords
- gait cycle, knee arthroplasty, wearable insole
- Medical subject headings
- Gait Disorders, Neurologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Case Series: clinical evaluation of gait cycle and ground in Knee arthroplasty patients
Evaluation of gait cycle and ground in primary TKA patients compared to the healthy contralateral limb.
Measured: baseline to 3 month
Secondary outcomes (1)
Perioperative Case Series: qualitative evaluation of gait cycle and ground in Knee arthroplasty patients
Easy of use. Qualitative user (HCP and patient) feedback on experience using and wearing the insoles
Measured: baseline to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start7 Nov 2017
- Primary completion9 Jan 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, UnsteadyStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Ulivi, Dr, Principal investigator, IRCCS Istituto Ortopedico GaleazziMilano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268680
- Sponsor's protocol ID
- OpenGO
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Case Series: Qualitative Evaluation of Gait Cycle and Ground in Knee
- ClinicalTrials.gov ID
- NCT04268680
- Acronym / sponsor ID
- OpenGO
- Conditions
- Gait, Unsteady
- Keywords
- gait cycle, knee arthroplasty, wearable insole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 13 Feb 2020 (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.
Gait analysis is a quick and powerful tool with a wide range of clinical applications in various fields. However, due to the expensive and highly specialized equipment required, gait studies are mostly limited to academic research centers and small sample sizes and no large-scale, randomized controlled trials have been performed. Several authors have proposed inexpensive accelerometer-based systems to remedy this situation. Through mathematic transformation they adequately measure step time and length. With these systems however only temporal spatial gait parameters can be recorded; kinetic gait parameters, such as ground reaction force, cannot be measured. As these kinetic parameters are important for clinical studies, especially in fracture and rehabilitation research different methods are needed. Its availability is mainly limited to research centers, conventional gait analysis is further hindered by its stationarity and that it only allows momentary views of the patient's gait in a confined research environment. Even smaller, wearable systems have to be attached to an external apparatus, or are limited by their battery capacity, data storage and other device specific factors. Furthermore, the use of these systems is at an early clinical stage and their full potential not yet developed. As most disease processes are continuous, tools with long-term, continuous measuring capabilities are needed. For this reason a new pressure-measuring insole with built in battery and data storage was developed in cooperation with the AO Foundation(AO Foundation, Davos, Switzerland). The system offers complete independence from any external measures for up to 4 weeks and monitors a patient step during this time.
The purpose of this pilot study is to investigate which how TKA arthroplasty may impact gait during early and medium term rehabilitation phase. This will be done through the use of the OpenGo Sensor Insole (Moticon GmbH).
Detailed description
Advanced degenerative arthropathies of the knee ultimately manifest as pain and a loss of function leading to impaired gait and activity. Total knee arthroplasty (TKA) is a procedure that aim to eliminate pain, restore the function of the joint and ultimately improve the ability of the patient to move and live an active life. TotalKneeArthroplasty has a history of success, but as the orthopedic and healthcare sectors evolve, a greater level of scrutiny and expectation for success will be applied to surgeons and device makers alike. In response to these elevated levels of scrutiny and expectation more advanced methods will likely be required to better capture and understand how a TotalKneeArthroplasty impacts patient function both on an individual, patient by patient, basis as well as on device design and surgical technique basis.
The present study is aimed at performing a preliminary evaluation to provide:
More advanced insight into a patient's functional recovery and rehabilitation with the potential for phisician's to intervene earlier and with greater specificity to any challenges encountered by the patient Objective evidence of the quality and value of the intervention on an individualized basis. Study objectives Any change in gait as a result of arthroplasty and dynamics of gait recovery during acute recovery and rehabilitation timeframe. Outcome measures will be gait cycle and ground: foot interaction dynamics which will be observed longitudinally and compared to the healthy contralateral limb (ground: foot interaction dynamics) as well literature data (gait cycle).
Primary objective:Evaluation of gait cycle and ground in primary TotalKneeArthroplasty patients compared to the healthy contralateral limb.
Secondary objectives:Easy of use. Qualitative user (Phisician and patient) feedback on experience using and wearing the insoles Study design:This is, single arm, prospective, single center, pilot study to measure the pre-operative and post-operative gait and ground: foot interaction dynamics of 6 subjects who are undergoing TotalKneeArthroplasty .
Data that will be collected at baseline (pre-op) besides the standard clinical data (VisualAnalogueScale, KneeSocietyScore SatisfactionForm-12, Knee Injury and Osteoarthritis Outcome Score(KOOS)) include: gait and ground: foot interaction dynamics during a prescribed in clinic activity as well as during activities of daily living.
Data that will be collected about the clinical follow-up include: gait and ground: foot interaction dynamics during a prescribed in clinic activity as well as during activities of daily living; user feedback regarding their experience using and wearing the insoles.
Total study duration for study participants will be 6 months with follow-up visits planned at: daily until discharge, 1 week, 2 weeks, 3 weeks, 3 months and 6 months. Full enrollement is estimated to require 1 months, therefore the total study duration is expected to be 7 months.
Subjects will be included in 1 Italian site. Data and user feedback will be analyzed continuously as they become available throughout the study period.
Patients selection:Once a subject has completed the informed consent procedure and signed the Informed Consent Form, the PI or delegated study research staff can complete the screening process with the subject. All potential subjects who undergo the screening process will be documented on a Screening and Enrollment Log, on which reasons for exclusion from or denial to participate should be noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by degenerative gonarthrosis who need a TKA in one of the two Knees
Key inclusion criteria (6 listed)
- primary TKA
- 45-75 years of age (included)
- skeletally mature
- willing and able to participate in required pre-op and follow-up visits at the investigational site and to complete study procedures and questionnaires
- consented to participating in the study by signing the IRB/EC approved informed consent form
Key exclusion criteria (2 listed)
- symptomatic/debilitating co-commitant arthropathy of non-operative joints (e.g. a TKA patient cannot have advanced arthritis of the contralateral knee or ipsilateral hip/ankle) that would impede or otherwise confuse the peri-operative measurement of gait.
- Significant comorbidities that would impede the patients ability to participate in standard recovery and rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative Case Series: clinical evaluation of gait cycle and ground in Knee arthroplasty patients
Time frame: baseline to 3 month
Evaluation of gait cycle and ground in primary TKA patients compared to the healthy contralateral limb.
1 secondary outcome
Perioperative Case Series: qualitative evaluation of gait cycle and ground in Knee arthroplasty patients
Time frame: baseline to 3 month
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 24 Apr 2020.
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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.
Michele Ulivi, Dr principal investigator
IRCCS Istituto Ortopedico GaleazziMilano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait, Unsteady, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 6 inclusion and 2 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 24 Apr 2020. 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 Italy. 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?
Perioperative Case Series: clinical evaluation of gait cycle and ground in Knee arthroplasty patients (time frame: baseline to 3 month). 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 24 Apr 2020.