Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles

NCT03440008 | Terminated Results

• 1 other identifier: F2318-W
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Control

Able-bodied, age matched subjects with no foot and ankle pathology

Other: Dynamic 3D bone motion capture

OA

Subjects with ankle OA, with all classifications of ankle misalignment (varus, neutral, valgus)

Other: Dynamic 3D bone motion capture; Device: wedged insole

Interventions

Dynamic 3D bone motion capture OTHER

Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment

Also known as: Biplane fluoroscopy

Control; OA

wedged insole DEVICE

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

Also known as: orthotic/insole

OA

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Controls and those with ankle osteoarthritis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens will be collected for this study

MeSH Terms

Interventions

Foot Orthoses

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Joseph Iaquinto
• Organization: VA Puget Sound Health Care System

Joseph.Iaquinto@va.gov

206-277-1738

Study Officials

• Joseph Iaquinto, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 20, 2018
• Study Start: December 22, 2016
• Primary Completion: March 10, 2020
• Study Completion: November 16, 2023
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)