Ankle OsteoarthritisODRSNCT02629731
Orthotic Dose Response Study
A study testing custom orthoses with varying degrees of hindfoot posting in people with Ankle Osteoarthritis and Flat Foot or Pes Planus, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This study will investigate the effect of foot orthoses on two common conditions (ankle osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system the group has developed to very accurately and precisely quantify foot bone motion. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Osteoarthritis, Flat Foot or Pes Planus
- What is being tested?
- custom orthoses with varying degrees of hindfoot posting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2016to 29 Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of ankle OA or PTTD [non-control subjects only]
- undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate
- between 18 and 80 years of age
- ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD
Who cannot join
- recent (<1 year) surgical, neurological, metabolic or lower limb musculoskeletal problem that might impair the ambulation measures in the study, such as severe knee or hip osteoarthritis
- rheumatoid arthritis or other inflammatory disease
- foot ulceration or partial foot amputation
- inadequate cognitive or language function to consent or to participate
- lack of a telephone number or stable mailing address
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
University of Washington
Seattle, Washington, 98195
About this study
Official title: Quantitative Prescription of Foot Orthoses: A Dose-Response Study of Kinematics in Patients With Foot and Ankle Pain Using Biplane Fluoroscopy
This study will investigate the effect of foot orthoses on two common conditions (ankle osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system the group has developed to very accurately and precisely quantify foot bone motion. The investigators will vary the design of the orthoses and subjects will be examined to find out which are most effective at improving function.
Read the detailed description
The aim with this proposal is to better understand how in-shoe foot orthoses achieve improvements in foot and ankle function for people with ankle osteoarthritis (OA) and/or adult acquired flatfoot resulting from posterior tibial tendon dysfunction (PTTD). The investigators also aim to be able to predict what the optimal, personalized orthotic device is for each patient is. These are common, painful, and often highly debilitating conditions, with ankle OA estimated to affect around 6% of the adult population and adult acquired flat foot around 3.3% percent of females. It has been shown that foot orthoses can be an effective conservative intervention for these conditions, and can help to postpone or negate surgery. However, for a significant proportion of patients foot orthoses are unsuccessful, and there is evidence that this may be a result of significant inter-individual variability in joint movement and loading response to the intervention. This may be due to a number of factors, including foot bone shape, muscle strength, and/or joint range of motion. In addition, the design of foot orthoses is often inconsistent between suppliers, largely because of the manual approach that is used to design and manufacture them. A further complicating factor is that prescriptions for foot orthoses are often vaguely written. Improving the investigators' understanding of different foot and ankle responses to variation in foot orthotic design is essential if the investigators are to improve how these devices function at the level of the individual patient. To measure how the individual bones of the foot move using traditional techniques is, however, very difficult. Such methods rely on skin-mounted markers that are tracked in space to determine foot and ankle kinematics. However the size and position of the foot and ankle bones means that it is not possible to measure them all of them individually. Moreover, the movement between the skin and the underlying bones, known as soft tissue artifact, introduces significant errors into the measurements. This is further complicated by the need to wear shoes for orthoses to function properly. The group has developed a biplane fluoroscopy system that is tailored to address the unique issues of measuring foot kinematics. This system has the additional advantage of being able to measure the effects of foot orthotics in unmodified shoes. To achieve the objective of understanding and being able to predict the effects of orthoses, the specific aims are:
- [1]: To collect, via biplane fluoroscopy, kinematic data describing the effect of varying the angle of hindfoot posting in foot orthotics. These data will be obtained from 90 participants: 30 with ankle OA; 30 with symptomatic PTTD; and 30 healthy controls.
- [2]: Using the data from SA1, carry out a regression analysis to identify factors obtained from biplane fluoroscopy and clinical exam that significantly influence an individual's response (i.e., hindfoot kinematics) to the orthotic intervention. These factors include: foot type, bone geometry, static foot posture, joint axis location, range of motion, and muscle strength.
- [3]: Using the data from SA1, generate a musculoskeletal model of the foot that allows detailed analysis of the muscles and ligaments controlling ankle movement. This will be developed in the OpenSim modeling platform and made freely available upon project completion.
- [4]: To compare the kinematic responses to orthotic devices prescribed using standard methods and those prescribed using algorithms and insight from SA2 and SA3 in a separate group of participants. Biplane fluoroscopy will be used to collect kinematic data from 10 patients with ankle OA and 10 with PTTD to compare the performance of the three pairs (one traditional, one from SA2 and one from SA3) of orthotics. This data will also be used to validate the predictions resulting from SA2 and SA3. This proposed research project will improve the investigators' understanding of how foot orthotics work and will help us to prescribe more effective devices to patients. This will benefit the large number of people in the population with ankle osteoarthritis and adult acquired flat foot.
- Conditions
- Ankle Osteoarthritis, Flat Foot or Pes Planus
- Being tested
- custom orthoses with varying degrees of hindfoot posting
- Keywords
- foot, ankle, osteoarthritis, flat foot
- Medical subject headings
- Flatfoot, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom orthoses with varying degrees of hindfoot postingDevice
The base orthotic design will be altered for one foot (most symptomatic in the case of patients or randomly chosen for controls) to give variations from 5-degree lateral hindfoot posting to 10-degree medial in 2.5-degree increments.
| Study group | Role | What they receive |
|---|---|---|
| ankle OA | Experimental | inclusion criteria: 1) diagnosis of ankle OA or PTTD [non-control subjects only], 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD Receives: Device: custom orthoses with varying degrees of hindfoot posting |
| flat foot | Experimental | inclusion criteria: 1) diagnosis of flat foot, 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) Receives: Device: custom orthoses with varying degrees of hindfoot posting |
| control | No intervention | inclusion criteria: 1) between 18 and 80 years of age, and 2) ambulatory (able to walk at least 15 m) |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak hindfoot eversion
In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics.
Measured: immediate
peak tibial rotation in degrees
In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study start1 Jul 2016
- Primary completion31 May 2022
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- William R. Ledoux, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629731
- Sponsor's protocol ID
- O2008-R
- Acronym
- ODRS
- Status last verified
- Jun 2024
- First submitted
- 2 Dec 2015
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Prescription of Foot Orthoses: A Dose-Response Study of Kinematics in Patients With Foot and Ankle Pain Using Biplane Fluoroscopy
- ClinicalTrials.gov ID
- NCT02629731
- Acronym / sponsor ID
- ODRS / O2008-R
- Conditions
- Ankle Osteoarthritis, Flat Foot or Pes Planus
- Keywords
- foot, ankle, osteoarthritis, flat foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Washington
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 14 Dec 2015 (estimated)
- 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.
This study will investigate the effect of foot orthoses on two common conditions (ankle osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system the group has developed to very accurately and precisely quantify foot bone motion. The investigators will vary the design of the orthoses and subjects will be examined to find out which are most effective at improving function.
Detailed description
The aim with this proposal is to better understand how in-shoe foot orthoses achieve improvements in foot and ankle function for people with ankle osteoarthritis (OA) and/or adult acquired flatfoot resulting from posterior tibial tendon dysfunction (PTTD). The investigators also aim to be able to predict what the optimal, personalized orthotic device is for each patient is. These are common, painful, and often highly debilitating conditions, with ankle OA estimated to affect around 6% of the adult population and adult acquired flat foot around 3.3% percent of females. It has been shown that foot orthoses can be an effective conservative intervention for these conditions, and can help to postpone or negate surgery. However, for a significant proportion of patients foot orthoses are unsuccessful, and there is evidence that this may be a result of significant inter-individual variability in joint movement and loading response to the intervention. This may be due to a number of factors, including foot bone shape, muscle strength, and/or joint range of motion. In addition, the design of foot orthoses is often inconsistent between suppliers, largely because of the manual approach that is used to design and manufacture them. A further complicating factor is that prescriptions for foot orthoses are often vaguely written. Improving the investigators' understanding of different foot and ankle responses to variation in foot orthotic design is essential if the investigators are to improve how these devices function at the level of the individual patient. To measure how the individual bones of the foot move using traditional techniques is, however, very difficult. Such methods rely on skin-mounted markers that are tracked in space to determine foot and ankle kinematics. However the size and position of the foot and ankle bones means that it is not possible to measure them all of them individually. Moreover, the movement between the skin and the underlying bones, known as soft tissue artifact, introduces significant errors into the measurements. This is further complicated by the need to wear shoes for orthoses to function properly. The group has developed a biplane fluoroscopy system that is tailored to address the unique issues of measuring foot kinematics. This system has the additional advantage of being able to measure the effects of foot orthotics in unmodified shoes. To achieve the objective of understanding and being able to predict the effects of orthoses, the specific aims are:
- [1]: To collect, via biplane fluoroscopy, kinematic data describing the effect of varying the angle of hindfoot posting in foot orthotics. These data will be obtained from 90 participants: 30 with ankle OA; 30 with symptomatic PTTD; and 30 healthy controls.
- [2]: Using the data from SA1, carry out a regression analysis to identify factors obtained from biplane fluoroscopy and clinical exam that significantly influence an individual's response (i.e., hindfoot kinematics) to the orthotic intervention. These factors include: foot type, bone geometry, static foot posture, joint axis location, range of motion, and muscle strength.
- [3]: Using the data from SA1, generate a musculoskeletal model of the foot that allows detailed analysis of the muscles and ligaments controlling ankle movement. This will be developed in the OpenSim modeling platform and made freely available upon project completion.
- [4]: To compare the kinematic responses to orthotic devices prescribed using standard methods and those prescribed using algorithms and insight from SA2 and SA3 in a separate group of participants. Biplane fluoroscopy will be used to collect kinematic data from 10 patients with ankle OA and 10 with PTTD to compare the performance of the three pairs (one traditional, one from SA2 and one from SA3) of orthotics. This data will also be used to validate the predictions resulting from SA2 and SA3. This proposed research project will improve the investigators' understanding of how foot orthotics work and will help us to prescribe more effective devices to patients. This will benefit the large number of people in the population with ankle osteoarthritis and adult acquired flat foot.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ankle OA | Experimental | Device: custom orthoses with varying degrees of hindfoot postinginclusion criteria: 1) diagnosis of ankle OA or PTTD [non-control subjects only], 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD |
| flat foot | Experimental | Device: custom orthoses with varying degrees of hindfoot postinginclusion criteria: 1) diagnosis of flat foot, 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) |
| control | No intervention | –inclusion criteria: 1) between 18 and 80 years of age, and 2) ambulatory (able to walk at least 15 m) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of ankle OA or PTTD [non-control subjects only]
- undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate
- between 18 and 80 years of age
- ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD
Key exclusion criteria (5 listed)
- recent (<1 year) surgical, neurological, metabolic or lower limb musculoskeletal problem that might impair the ambulation measures in the study, such as severe knee or hip osteoarthritis
- rheumatoid arthritis or other inflammatory disease
- foot ulceration or partial foot amputation
- inadequate cognitive or language function to consent or to participate
- lack of a telephone number or stable mailing address
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 |
|---|---|---|
| custom orthoses with varying degrees of hindfoot postingThe base orthotic design will be altered for one foot (most symptomatic in the case of patients or randomly chosen for controls) to give variations from 5-degree lateral hindfoot posting to 10-degree medial in 2.5-degree increments. | Device | ankle OA, flat foot |
Primary outcome
peak hindfoot eversion
Time frame: immediate
In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics.
peak tibial rotation in degrees
Time frame: immediate
In the proposed experiments, normal and pathological subjects will be studied while they walk with seven different designs of in-shoe orthoses in standardized footwear. Subjecting individuals to different "doses" of orthotic correction will generate "dose-response" curves (i.e., the kinematic variables) that will then be associated with patient-specific characteristics.
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 21 Jun 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.
William R. Ledoux, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom orthoses with varying degrees of hindfoot posting in people with Ankle Osteoarthritis and Flat Foot or Pes Planus, run by VA Office of Research and Development at 2 sites in United States.
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 4 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
peak hindfoot eversion (time frame: immediate). The study lists 2 primary outcomes in all. 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 21 Jun 2024.