Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles

Ankle Osteoarthritis Clinical Trial

— IDCT  

Official title:

Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03440008
• Other study ID #: F2318-W
• Status: Active, not recruiting
• Start date: November 13, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

"As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment has been placed on temporary administrative hold as of 03/16/2020."

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Intervention

Other:
• Dynamic 3D bone motion capture
Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment

Device:
• wedged insole
medial or lateral wedge (appropriate for varus or valgus misalignment) will be applied during 1 data collection session to evaluate effect of wedging on misalignment

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tibio-talar kinematics during gait	The 3D movement between the tibia and talus bones will be assessed using biplane fluoroscopy, for OA and control subjects during shod gait.	4 hour session
Primary	Static ankle alignment sensitivity	The sensitivity to correctly diagnose dynamic misalignment by using static x-ray images, will be determined for the OA population.	4 hour session
Primary	Decrease in misalignment during gait using wedged insoles	The effect that wedged insoles have on varus / valgus misalignment will be assessed using dynamic 3D x-ray	4 hour session