Custom Dynamic Orthoses to Reduce Articular Contact Stress (PRMRP FPA CT)

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle. Research suggests that ankle arthritis develops following ankle fracture due, in part, to elevated forces on the cartilage. It is expected that carbon fiber braces can reduce forces in the ankle joint thereby reducing the risk of developing arthritis following injury. In this study, carbon fiber braces will be tested to determine how they influence the forces acting on the ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design carbon fiber braces to effectively reduce forces on ankle cartilage.

Study Overview

• Status: Withdrawn
• Conditions: Post-traumatic Osteoarthritis; Ankle Fractures; Osteoarthritis Ankle
• Intervention / Treatment: Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Detailed Description

The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) use on forces and contact stress at the ankle, with the goal of reducing the development of post traumatic osteoarthritis (PTOA). Research suggests that PTO develops, in part, due to increased ankle contact stress following fracture. It is expected that reducing articular contact stress has the potential to delay or prevent PTOA development. CDOs have been shown to significantly improve function after extremity injury, and show promise for offloading the injured ankle joint after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate CDOs effects on forces and articular contact stress at the ankle.

Adult participants who have sustained a traumatic ankle fracture of the tibial pilon will be evaluated while wearing two CDOs, with a primary dependent measure of ankle joint contact stress. Following consent and enrollment weight bearing computerized tomography (CT) images will be collected and used to determine the geometry of the joint, and the articular contact stress using discrete element analysis.

Participants will be cast and fit for two CDOs. Participants will be blinded to the design variation of each device and will only know them as CDO-A or CDO-B. Testing will be completed under 3 conditions: No-CDO, CDO-A, CDO-B, with each bracing condition (A/B) representing a different CDO. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that the CDOs do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without using a CDO, satisfaction with the study CDOs, perception of comfort and smoothness between CDOs, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective with each study CDO. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates embedded in the floor. Forces between the foot and CDO footplate will be measured using force sensing insoles, and muscle activity data will be collected using wireless surface electromyography sensors. Each CDO will be mechanically tested, and participant demographic and anthropometric data will be recorded.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason M Wilken, PT, PhD; Phone Number: 3193356857; Email: jason-wilken@uiowa.edu
• Study Contact Backup: Name: Kirsten M Anderson, BSE; Phone Number: 3193530431; Email: kirsten-m-anderson@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52241
      • University of Iowa
      • Contact: Jason M Wilken, PT, PhD; Phone Number: 3193356857; Email: jason-wilken@uiowa.edu
      • Contact: Kirsten M Anderson, BSE; Phone Number: 3193530431; Email: kirsten-m-anderson@uiowa.edu
      • Sub-Investigator: Molly Pacha, MS, ATC, LAT
      • Sub-Investigator: Michael C Willey, MD
      • Sub-Investigator: Jeff Palmer, CPO, LPO
      • Sub-Investigator: Donald D Anderson, PhD
      • Principal Investigator: Jason M Wilken, PT, PhD
      • Sub-Investigator: Cesar De Cesar Netto, MD
      • Sub-Investigator: Matthew Karam, MD
      • Sub-Investigator: J Lawrence Marsh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between the ages of 18 and 65
• Sustained unilateral fracture of the tibial pilon
• The fracture has completely healed
• Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.)
• Ability to walk at a slow to moderate pace
• Shoe size between women's 8 and 13.5 or men's 6.5 and 12
• Ability to read and write in English and provide written informed consent
• Individuals with elevated contact stress according to model generated using standing CT images (will be answered after completing visit one)

Exclusion Criteria:

• Pain > 6/10 while walking
• Increase in pain during testing of 3/10 or greater
• Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity
• Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease)
• Wounds to the calf that would prevent CDO fitting
• Fractures secondary to neuropathy or severe osteopenia
• Classification as non-ambulatory
• Previous fractures near the tibial pilon on the involved limb
• Surgery on involved limb anticipated in the next 6 months
• Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities
• Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
• BMI greater than 40
• Pregnancy- Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: NoCDO; Participants will be evaluated without a CDO
Experimental: CDO-A; The first study CDO will be designated CDO-A	Device: Carbon Fiber Custom Dynamic Orthosis (CDO); The carbon fiber custom dynamic orthosis will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.; Other Names: Ankle Foot Orthosis (AFO)
Experimental: CDO-B; The second study CDO will be designated CDO-B	Device: Carbon Fiber Custom Dynamic Orthosis (CDO); The carbon fiber custom dynamic orthosis will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.; Other Names: Ankle Foot Orthosis (AFO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.	Baseline
Joint Contact Stress Exposure (Model estimated)	Joint contact stress exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.	Baseline
Participant Device Preference	The participant will rank order their preference for their standard of care device (if applicable), NoCDO, CDO-A, CDO-B on a questionnaire.	Baseline
Peak Plantar Force (total foot)	Plantar forces (N) will be measured across the forefoot (100% of sensor) as participants walk without a CDO and with each CDO.	Baseline
Plantar Force Impulse (total foot)	Plantar force impulse (Ns) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.	Baseline
Peak Plantar Force (forefoot)	Plantar forces (N) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.	Baseline
Plantar Force Impulse (forefoot)	Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.	Baseline
Peak Plantar Force (midfoot)	Plantar forces (N) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.	Baseline
Plantar Force Impulse (midfoot)	Plantar force impulse (Ns) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.	Baseline
Peak Plantar Force (hindfoot)	Plantar forces (N) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.	Baseline
Plantar Force Impulse (hindfoot)	Plantar force impulse (Ns) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Four Square Step Test (4SST)	The 4SST (s) is a standardized timed test of balance and agility.	Baseline
Sit to Stand 5 Times (STS5)	STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.	Baseline
Ankle Range of Motion	Ankle range of motion (degrees) during gait.	Baseline
Peak Ankle Moment	Peak ankle moment (Nm/kg) during gait.	Baseline
Peak Ankle Power	Peak ankle power (W/kg) during gait.	Baseline
The Orthotics Prosthetics Users' Survey (OPUS)	Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.	Baseline
Modified Socket Comfort Score (Comfort)	Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.	Baseline
Modified Socket Comfort Score (Smoothness)	Smoothness scores range from 0 = least smooth to 10 = most smooth.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center of pressure velocity timing	Timing of peak center of pressure velocity (percent stance) during gait.	Baseline
Center of pressure velocity magnitude	Magnitude of peak center of pressure velocity (m/s) during gait.	Baseline
Soleus Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the soleus during gait.	Baseline
Tibialis Anterior Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of theTibialis Anterior during gait.	Baseline
Medial Gastrocnemius Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.	Baseline
Rectus Femoris Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.	Baseline
Vastus Medialis Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.	Baseline
Semi-Structured Interview	Semi-structured interviews will also be used to fully capture the patients' perspectives, experience, and opinions associated with the device options they experienced as part of the study.	Baseline

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Arthritis; Adult; Biomechanics; Gait Analysis; Ankle; Carbon Fiber; Ankle Foot Orthosis
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Ankle Injuries; Osteoarthritis; Ankle Fractures; Anti-Infective Agents, Local; Anti-Infective Agents; Carbon Fiber
• Other Study ID Numbers: 202112331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No