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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.
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 groups in NCT02629731
Study groupRoleWhat they receive
ankle OAExperimentalinclusion 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 footExperimentalinclusion 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
controlNo interventioninclusion 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.

  1. 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

  2. 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.

  1. First posted14 Dec 2015 (estimated)
  2. Study start1 Jul 2016
  3. Primary completion31 May 2022
  4. Study completion29 Dec 2023

Resources

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)
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

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.

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