Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot

NCT05293743 | Completed Results DMC

• 1 other identifier: 1000078967
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate a new Dynamic Bar for foot abduction bracing for clubfoot treatment. The main questions that this study aims to answer are:

• How easy is it to recruit and retain participants for a randomized-controlled effectiveness trial of a novel foot abduction bar?
• How does parental perception of child comfort in the Dynamic Bar compare to parental perception of child comfort in standard bars?
• How does patient tolerance of the Dynamic Bar compare patient tolerance of standard bars?
• How effective is the Dynamic Bar at preventing clubfoot recurrence during the bracing phase when the brace is worn as prescribed for a 30-day trial period? Each participant will be randomized into one of two arms: the experimental arm or the control arm. For the first 30 days, the experimental arm will wear the new Dynamic Bar with standard boots and the control arm will continue wearing their standard bar. After this 30-day period, the experimental arm will return to wearing their standard bar.

Conditions

Clubfoot

Outcome Measures

Primary Outcomes (3)

• Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types

  The study's recruitment rate was calculated to evaluate the ease of recruiting participants for a randomized-controlled effectiveness trial of a novel foot abduction bar. A recruitment rate less than 50% is considered a poor indicator for ease of recruitment and protocols for a future study should be revisited to improve recruitment strategies.

  Recruitment period lasted approximately 8 months.

• Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types

  The dropout rate was calculated to evaluate the ease of retaining participants for a randomized-controlled effectiveness trial of a novel FAB bar. A dropout rate greater than 20% is considered a poor indicator for ease of participant retention.

  Study period lasted approximately 90 days.

• Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types

  On the first day of the study, parents were asked in a questionnaire if they had any concerns about participating in the study. On the last day of the study, parents were asked if they would be interested in participating in a future study of the Dynamic Bar. These questions were asked to evaluate the ease of achieving parent satisfaction during a randomized-controlled effectiveness trial of a novel FAB bar.

  Study period lasted approximately 90 days.

Secondary Outcomes (8)

• Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar

  Study period lasted approximately 90 days.

• Parental Perception of Child Comfort - Preferred Bar

  Parents were asked to indicate their preferred bar for clubfoot bracing at the end of the study's intervention period (after approximately 30 days) and on the last day of the study (after approximately 90 days).

• Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar

  Study period lasted approximately 90 days.

• Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses

  Intervention period lasted approximately 30 days.

• Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average

  Intervention period lasted approximately 30 days.

Other Outcomes (1)

• Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar

  Each video recording was approximately 2 minutes in length.

Study Arms (2)

Standard Bar

ACTIVE COMPARATOR

This group will continue using the Standard Bar as part of their brace, per their current treatment.

Device: Foot abduction bracing for clubfoot with Standard Bar

Dynamic Bar

EXPERIMENTAL

This group will use the Dynamic Bar for 30 days instead of their Standard Bar.

Device: Foot abduction bracing for clubfoot with novel Dynamic Bar

Interventions

Foot abduction bracing for clubfoot with novel Dynamic Bar DEVICE

After Ponseti treatment of serial casting and tenotomy for clubfoot, patients are braced full time x 3 months then night time until age 5. This study compares standard bars in a foot abduction brace to our novel Dynamic Bar. This group uses the Dynamic Bar.

Dynamic Bar

Foot abduction bracing for clubfoot with Standard Bar DEVICE

After Ponseti treatment of serial casting and tenotomy for clubfoot, patients are braced full time x 3 months then night time until age 5. This study compares standard bars in a foot abduction brace to our novel Dynamic Bar. This group uses the Standard Bar.

Standard Bar

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ability of parent/care giver to complete brace wear log/surveys in English
• Diagnosis of idiopathic clubfoot (unilateral or bilateral).
• Current use of a SB with their Foot Abduction Brace.
• In the minimum 12-hour per day bracing stage of the Ponseti treatment
• Aged 1 to 3 years (as the DB prototype was designed based on the average size and strength of a child within that age group).
• Well-corrected clubfoot/clubfeet (Pirani score ≤ 0.5)
• Enrollment in the SickKids Clubfoot Research Registry.

You may not qualify if:

• Recurrent clubfoot deformity at time of recruitment and/or Day 0 in study period: Pirani score above 0.5; Presence of cavus, adduction, or hindfoot varus; Less than 10 degrees of passive ankle dorsiflexion.
• Current complaint of significant brace intolerance.
• Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk, i.e., skin conditions such as eczema, neurologic conditions or any non-idiopathic clubfoot, any acute or chronic illness perceived to be causing the child discomfort such as a cold or flu or other concurrent painful procedure.
• The patient does not adequately fit the available prototype, e.g., shoulder width distance is too narrow or wide for prototype bar width. However, these patients will be recorded in the study enrollment log to identify the size of this subset. The age and fit issues of these patients will also be recorded to allow future adaptations of the new DB to accommodate this subset.
• The patient is using an older boot model, in which a temperature sensor cannot be inserted, and the patient does not adequately fit the available boots, in which the temperature sensors have already been installed.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (23)

• Anand A, Sala DA. Clubfoot: etiology and treatment. Indian J Orthop. 2008 Jan;42(1):22-8. doi: 10.4103/0019-5413.38576.

  PMID: 19823650 BACKGROUND

• Alves C. Bracing in clubfoot: do we know enough? J Child Orthop. 2019 Jun 1;13(3):258-264. doi: 10.1302/1863-2548.13.190069.

  PMID: 31312265 BACKGROUND

• Hospital for Special Surgery [Internet]. New York: HSS. Method for Correcting Clubfoot: Overview for Parent; 2019 Sept 12 [cited 2021 Jan 11] Available from: https://www.hss.edu/conditions_thse-ponseti-method-for-clubfoot-correction.asp.

  BACKGROUND

• Garg S, Porter K. Improved bracing compliance in children with clubfeet using a dynamic orthosis. J Child Orthop. 2009 Aug;3(4):271-6. doi: 10.1007/s11832-009-0182-9. Epub 2009 Jun 3.

  PMID: 19495824 BACKGROUND

• SickKids Internal Document. CLUBFOOT FAO BAR OPTIONS June 2017 edited. 2017 June.

  BACKGROUND

• Azarpira MR, Emami MJ, Vosoughi AR, Rahbari K. Factors associated with recurrence of clubfoot treated by the Ponseti method. World J Clin Cases. 2016 Oct 16;4(10):318-322. doi: 10.12998/wjcc.v4.i10.318.

  PMID: 27803913 BACKGROUND

• Zhao D, Liu J, Zhao L, Wu Z. Relapse of clubfoot after treatment with the Ponseti method and the function of the foot abduction orthosis. Clin Orthop Surg. 2014 Sep;6(3):245-52. doi: 10.4055/cios.2014.6.3.245. Epub 2014 Aug 5.

  PMID: 25177447 BACKGROUND

• American Academy of Orthopaedic Surgeons [Internet]. Illinois: AAOS. Study Finds Ponseti Method Remains an Effective Treatment for Clubfoot, Bracing Is Paramount; 2021 Jan 18 [cited 2021 May 25] Available from: https://www.aaos.org/aaosnow/2020/aaos-now-special-edition/research/662_pediatrics.

  BACKGROUND

• Gelfer Y, Wientroub S, Hughes K, Fontalis A, Eastwood DM. Congenital talipes equinovarus: a systematic review of relapse as a primary outcome of the Ponseti method. Bone Joint J. 2019 Jun;101-B(6):639-645. doi: 10.1302/0301-620X.101B6.BJJ-2018-1421.R1.

  PMID: 31154846 BACKGROUND

• Morgenstein A, Davis R, Talwalkar V, Iwinski H Jr, Walker J, Milbrandt TA. A randomized clinical trial comparing reported and measured wear rates in clubfoot bracing using a novel pressure sensor. J Pediatr Orthop. 2015 Mar;35(2):185-91. doi: 10.1097/BPO.0000000000000205.

  PMID: 24787312 BACKGROUND

• Aroojis A, Pandey T, Dusa A, Krishnan AG, Ghyar R, Ravi B. Development of a functional prototype of a SMART (Sensor-integrated for Monitoring And Remote Tracking) foot abduction brace for clubfoot treatment: a pre-clinical evaluation. Int Orthop. 2021 Sep;45(9):2401-2410. doi: 10.1007/s00264-021-05042-0. Epub 2021 Apr 22.

  PMID: 33885922 BACKGROUND

• Sangiorgio SN, Ho NC, Morgan RD, Ebramzadeh E, Zionts LE. The Objective Measurement of Brace-Use Adherence in the Treatment of Idiopathic Clubfoot. J Bone Joint Surg Am. 2016 Oct 5;98(19):1598-1605. doi: 10.2106/JBJS.16.00170.

  PMID: 27707845 BACKGROUND

• Masrouha KZ, Moses MJ, Sala DA, Litrenta J, Lehman WB, Chu A. The Validity of Patient-reported Outcome Measurement Information System (PROMIS) Parent Proxy Instruments to Assess Function in Children With Talipes Equinovarus. J Pediatr Orthop. 2019 Nov/Dec;39(10):e787-e790. doi: 10.1097/BPO.0000000000001368.

  PMID: 30913133 BACKGROUND

• Varni JW, Limbers CA, Burwinkle TM. How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jan 3;5:1. doi: 10.1186/1477-7525-5-1.

  PMID: 17201920 BACKGROUND

• Mitchell JR, inventor. Quick clip for a club foot device. United States patent US 20160113803A1. 2002 Jun 9.

  BACKGROUND

• C-Pro Direct [Internet]. Ponseti AFO Standard Sandals with Bar; [cited 2021 May 25] Available from: https://c-prodirect.com/ponseti-afo-standard-sandals-with-bar.

  BACKGROUND

• MD Orthopaedics [Internet]. Massachusetts: MD Orthopaedics. Ponseti® Bar; [cited 2021 May 25] Available from: https://mdorthopaedics.easyordershop.com/link/en/bars/ponseti/a/.

  BACKGROUND

• iButtonLink Technology [Internet]. DS1922L-F5# Thermochron iButton 8K -40 to 85°C; [cited 2021 July 1] Available from: https://www.ibuttonlink.com/products/ds1922l.

  BACKGROUND

• Dobbs MB, Frick SL, Mosca VS, Raney E, VanBosse HJ, Lerman JA, Talwalkar VR, Steger-May K, Gurnett CA. Design and descriptive data of the randomized Clubfoot Foot Abduction Brace Length of Treatment Study (FAB24). J Pediatr Orthop B. 2017 Mar;26(2):101-107. doi: 10.1097/BPB.0000000000000387.

  PMID: 27632641 BACKGROUND

• Tamarack Habilitation Technologies, Inc. [Internet] ShearBan® Self-Adhesive, Low-Friction Sheets for Foot Blister and Ulcer Care; [cited 2021 August 2] Available from: https://tamarackhti.com/resources/shearban

  BACKGROUND

• Youtube [Internet]. Installing I-Button in Ponseti AFO; [cited 2021 July 1] Available from: https://www.youtube.com/watch?v=YACSbFn-lOA.

  BACKGROUND

• Sadler B, Gurnett CA, Dobbs MB. The genetics of isolated and syndromic clubfoot. J Child Orthop. 2019 Jun 1;13(3):238-244. doi: 10.1302/1863-2548.13.190063.

  PMID: 31312262 BACKGROUND

• D-Bar Enterprises [Internet]. Missouri: D-Bar Enterprises. Product Guide and Catalog ® Bar; 2015 [cited 2021 May 27] Available from: https://www.dobbsbrace.com/products.

  BACKGROUND

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Recruitment closed early, due to limited hospital resources, leading to a small number of subjects analyzed. Several large discrepancies were noted between the iButton sensor data and the brace log data. This calls into question the reliability of iButton sensors in accurately measuring brace wear in clubfoot treatment. Additionally, the sensors only recorded the temperature every 45 minutes due to limited data storage; this increases the error associated with the brace wear calculations.

Results Point of Contact

• Title: Dr. Maryse Bouchard
• Organization: The Hospital for Sick Children

maryse.bouchard@sickkids.ca

4168137654

Study Officials

• Maryse Bouchard, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinician assessing foot shape for recurrence will be blinded to the brace type. Clinicians involved in fitting the brace will not be.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Experimental arm with new device, control arm with standard device.

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: March 24, 2022
• Study Start: August 17, 2022
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: May 22, 2025
• Results First Posted: November 25, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)