Study Summary
This trial is evaluating a new dynamic bar for foot abduction bracing for clubfoot treatment. Eligible patients must have a well-corrected idiopathic clubfoot and be in the minimum 12 hours per day bracing stage of the Ponseti clubfoot treatment protocol. The overall study period will be 90 days in length.
Eligible Conditions
- Clubfoot
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: 90 days
90 days
Feasibility of recruitment for a prospective trial comparing clubfoot brace types.
Parent perception of child comfort in brace
Patient tolerance of brace based on hours brace worn
Preliminary assessment of brace effectiveness
Retention of patients for a prospective trial comparing clubfoot brace types.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Straight bar
1 of 2
Dynamic bar
1 of 2
Active Control
Experimental Treatment
20 Total Participants · 2 Treatment Groups
Primary Treatment: Dynamic bar · No Placebo Group · N/A
Dynamic bar
Device
Experimental Group · 1 Intervention: Foot abduction bracing for clubfoot with novel dynamic bar · Intervention Types: DeviceStraight bar
Device
ActiveComparator Group · 1 Intervention: Foot abduction bracing for clubfoot with standard straight bar · Intervention Types: DeviceTrial Logistics
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
644 Previous Clinical Trials
6,816,209 Total Patients Enrolled
Maryse Bouchard, MDPrincipal InvestigatorThe Hospital for Sick Children
Eligibility Criteria
Age 1 - 3 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are currently receiving Ponseti treatment and wearing a brace for at least 12 hours a day.
Your clubfoot has been successfully treated and corrected by a doctor.
You have been diagnosed with clubfoot without a known cause (on one or both feet).
References
- 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.
- 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. Review.
- Mitchell JR, inventor. Quick clip for a club foot device. United States patent US 20160113803A1. 2002 Jun 9.
- 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.
- 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.
- 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.
- 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.
- SickKids Internal Document. CLUBFOOT FAO BAR OPTIONS June 2017 edited. 2017 June.
- 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.
- Youtube [Internet]. Installing I-Button in Ponseti AFO; [cited 2021 July 1] Available from: https://www.youtube.com/watch?v=YACSbFn-lOA.
- 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.
- 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.
- 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.
- Anand A, Sala DA. Clubfoot: etiology and treatment. Indian J Orthop. 2008 Jan;42(1):22-8. doi: 10.4103/0019-5413.38576.
- 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.
- 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
- iButtonLink Technology [Internet]. DS1922L-F5# Thermochron iButton 8K -40 to 85°C; [cited 2021 July 1] Available from: https://www.ibuttonlink.com/products/ds1922l.
- 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.
- 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.
- 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.
- MD Orthopaedics [Internet]. Massachusetts: MD Orthopaedics. Ponseti® Bar; [cited 2021 May 25] Available from: https://mdorthopaedics.easyordershop.com/link/en/bars/ponseti/a/.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Maryse Bouchard 2022. "Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05293743.
Frequently Asked Questions
Does this research include participants who are above the age of 20?
"This trial is enrolling participants between the ages of 1 and 3 years old." - Anonymous Online Contributor
Unverified Answer
Is this experiment actively seeking participants?
"According to clinicaltrials.gov, this study is accepting applicants as of now. The trial was initially put forward on July 5th 2022 and has been amended most recently on October 21st 2022." - Anonymous Online Contributor
Unverified Answer
How many participants are currently engaging in this research?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical investigation is currently recruiting participants for its inaugural cohort. First posted on July 5th 2022 and most recently updated October 21st 2022, the trial requires 20 volunteers from a single research facility." - Anonymous Online Contributor
Unverified Answer
Who is qualified to partake in this experiment?
"This clinical trial is seeking 20 toddlers aged between one and three who are diagnosed with clubfoot. To be eligible, the parent/caregiver must have a grasp of English to complete brace wear log/surveys, as well as meet other criteria such as current use of a standard SB with their Foot Abduction Brace., being in the minimum 12-hour per day bracing stage of Ponseti treatment, having a Pirani score ≤ 0.5, and enrolling in the SickKids Clubfoot Research Registry.." - Anonymous Online Contributor
Unverified Answer