Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles



Status:Recruiting
Conditions:Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:45 - 70
Updated:11/16/2018
Start Date:November 13, 2018
End Date:December 31, 2021
Contact:Jennifer G Hicks
Email:jennifer.hicks4@va.gov
Phone:(206) 764-2962

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The Veteran population is prone to foot and ankle maladies from common injuries such as
sprains, and diseases such as ankle osteoarthritis (cartilage damage). More specific to
Veterans are prior service injuries of the foot and ankle, which historically account for
nearly a quarter of injuries received. These injuries include bone fractures and ligament
damage. Some of these injuries may lead to poor ankle joint alignment, which over time could
lead to osteoarthritis due to abnormal wear on a day to day basis. The goal of this proposal
is to use a novel technology - biplane fluoroscopy, to study the movement of ankles which are
misaligned in subjects with ankle osteoarthritis. This proposal will also benefit current
diagnostic methods with additional information. Last, this proposal will test the
effectiveness of a conservative treatment (modified shoe insoles) to correct or reduce the
misalignment in ankles. This proposal will create evidence about: the nature of ankle
osteoarthritis, the accuracy of diagnosing alignment, and conservative treatment for patients
with ankle OA.

Ankle osteoarthritis (OA) is a debilitating and mobility limiting condition. It can commonly
stem from the result of a traumatic injury - such trauma has a high prevalence in military
service. If cartilage is not severely damaged in that trauma, the stability and alignment of
the joint may be. Over time, an unstable or misaligned ankle joint can experience abnormal
rates of cartilage wear and tear due to aberrant kinematics. While OA may take decades to
develop, the resulting arthritic state from this trauma will ultimately require ankle
replacement or fusion, consequences with a tremendous financial burden and quality of life
impact.

With regards to alignment, particularly in the coronal plane, current clinical diagnosis
relies on static X-ray of the ankle joint. Static images may not indicate dynamic
misalignment during gait. Further, the effect of wedged insoles, a potential conservative
treatment, on the restoration of ankle function is undocumented.

This proposal aims to use biplane fluoroscopy, an X-ray based dynamic imaging approach, to
measure ankle kinematics in OA subjects (with varus, neutral and valgus ankle alignment) and
controls. With this method, tibio-talar kinematics during gait can be measured. Furthermore,
subjects classified as neutral from their static radiograph, but that exhibit ankle varus or
valgus alignment during gait, will be identified. Improving the accuracy of a diagnostic
outcome provides a patient group with additional avenues for treatment. The investigators
will investigate correlations between the investigators' 3D kinematics and clinical 2D
imaging - to the benefit of clinical diagnostics. The investigators will also be able to
measure the effect of wedged insoles on the restoration of ankle function. With this in mind,
the following aims and methodology are proposed.

Specific Aim 1: To investigate ankle kinematics in controls and subjects with OA. In support
of Specific Aim 1, 90 ankle OA subjects will be recruited (30 each of varus, neutral or
valgus aligned ankles). The investigators will also recruit 20 control subjects. Subjects
will receive CT scans of their feet to quantify bone geometry (a step necessary for biplane
fluoroscopy). Subjects will then be imaged in the biplane system during gait trials and while
wearing neutral study shoes. This will yield tibio-talar kinematics during gait for these
populations. Specific Aim 2: To identify dynamically misaligned ankles in OA subjects who are
currently classified as neutrally aligned using static analysis. The investigators will
compare the static X-ray and the gait kinematics of OA subjects, particularly those with
clinically determined neutral alignment. The investigators will determine what proportion of
neutral OA subjects actually exhibit misalignment during gait and are thus improperly
categorized. The investigators will also re-create 2D clinical X-ray views from the
investigators' 3D data in an attempt to translate the investigators' improvement (with 3D
fluoroscopy) to more accurately classify alignment to clinical 2D diagnostics. Specific Aim
3: To evaluate the potential of lateral or medial wedging to restore alignment in misaligned
ankle OA subjects. OA subjects will be imaged wearing shoes with wedged insoles which
correspond to their type of misalignment. Neutral OA subjects, who demonstrate misalignment
during gait, will be recalled for a wedged insole session. This yields conservative treatment
kinematics.

This study will generate baseline data describing the kinematics of control and ankle OA
subjects. This data is not currently available in the literature, and represents a novel
contribution to the field. Second, this proposal determines how accurate current 2D X-ray
methods are at detecting dynamic misalignment. This information can inform clinicians about
the accuracy of their diagnostic tools, and may lead to improvements. Third, this proposal
will generate data to evaluate the utility of wedged insoles for the conservative management
of ankle misalignment. In Summary, this study has immediate impact potential on the diagnosis
and treatment of ankle OA. Last, there are numerous additional avenues of classification,
diagnostic, and preventative research for the benefit of the Veterans which will stem from
this Career Development Award.

Inclusion Criteria:

- Be ambulatory (able to walk at least 15 m, and tolerate ~1 hour of standing and
walking with rest periods)

Exclusion Criteria:

- 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

- Diagnosed with diabetes, peripheral neuropathy, or peripheral vascular disease

- For OA subjects, a radiographic discontinuity of the cartilage of the tibial plafond
or talar dome

- Also for OA subjects, rapid onset of OA (<3 years) following ankle fracture

- Diagnosis of severe ankle instability or deformity such as pes planus

- Inadequate cognitive or language function to consent or to participate
We found this trial at
1
site
Seattle, Washington 98108
Principal Investigator: Joseph Iaquinto, PhD
Phone: 206-764-2962
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mi
from
Seattle, WA
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