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Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05293743
Recruitment Status : Not yet recruiting
First Posted : March 24, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Maryse Bouchard, The Hospital for Sick Children

Brief Summary:

This is an assessor-blinded randomized feasibility trial evaluating a new dynamic bar for foot abduction bracing for clubfoot treatment. Eligible patients must have a well-corrected idiopathic clubfoot (Pirani Score ≤ 0.5) 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. For the first 30 days, the experimental cohort will wear the new Dynamic Bar (DB) with standard ankle-foot orthoses (boots) and the control cohort will continue wearing the standard Ponseti Straight Bar (SB). After this 30-day period, the experimental cohort will return to wearing their standard Ponseti SB.

All patients will be evaluated on Day 0, Day 7, Day 30, and Day 90 of the study period to monitor for recurrence of the clubfoot deformity, complications of brace wearing, to submit brace wear logs, and to complete parent-reported questionnaires regarding their perceptions of the Foot Abduction Brace (FAB) and their child's comfort. A minimum of 10 patients per arm will be recruited. A temperature sensor will be added in each participant's boots during the 90-day study period to objectively measure time of brace wear. It is hypothesized that when patients are wearing the DB they will experience higher brace tolerance defined as increased wear time of the brace as measured by the temperature sensors, and higher comfort levels as reported by parents, without an increase in clubfoot deformity recurrence compared to the SB.


Condition or disease Intervention/treatment Phase
Clubfoot Device: Foot abduction bracing for clubfoot with novel dynamic bar Device: Foot abduction bracing for clubfoot with standard straight bar Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 10 patients per arm (only 10 total will try new device, 10 as controls with standard device)
Masking: Single (Outcomes Assessor)
Masking Description: The clinician assessing foot shape for recurrence will be blinded to the brace type. Clinicians involved in fitting the brace will not be.
Primary Purpose: Device Feasibility
Official Title: Development and Evaluation of Novel Dynamic Bar for Foot Abduction Brace for Clubfoot Treatment
Estimated Study Start Date : July 5, 2022
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: Straight bar
This group will continue using the straight bar as part of their brace, per their current treatment.
Device: Foot abduction bracing for clubfoot with standard straight bar
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 the standard straight bar in a foot abduction brace to our novel dynamic bar. This group uses the standard bar.

Experimental: Dynamic bar
This group will use the novel dynamic bar for 30 days instead of their standard straight bar.
Device: Foot abduction bracing for clubfoot with novel dynamic bar
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 the standard straight bar in a foot abduction brace to our novel dynamic bar. This group uses the novel bar.




Primary Outcome Measures :
  1. Feasibility of recruitment for a prospective trial comparing clubfoot brace types. [ Time Frame: 90 days ]
    To evaluate the ease of recruiting participants for a randomized-controlled effectiveness trial of a novel FAB bar. This will be defined as time required to recruit desired sample size - if over 3 months it will be considered difficult and protocols for a future study should be revisited to improve recruitment strategies.

  2. Retention of patients for a prospective trial comparing clubfoot brace types. [ Time Frame: 90 days ]
    To evaluate the ease of retaining participants for a randomized-controlled effectiveness trial of a novel FAB bar. Retention will be defined as the dropout rate. We hope for 100% retention or a 0% dropout rate. Anything over 20% drop out will be considered a poor indicator for ease of participant retention.


Secondary Outcome Measures :
  1. Parent perception of child comfort in brace [ Time Frame: 90 days ]
    To compare parental perception of the child's comfort in the SB versus the DB for foot abduction bracing in Ponseti clubfoot treatment.

  2. Patient tolerance of brace based on hours brace worn [ Time Frame: 90 days ]
    To compare patient tolerance of the SB to the DB as measured by parent self-reporting and by how many hours the brace is worn per day as recorded by temperature sensors placed in the boots.


Other Outcome Measures:
  1. Preliminary assessment of brace effectiveness [ Time Frame: 90 days ]
    To perform a preliminary assessment of the effectiveness of the DB at preventing clubfoot recurrence during the bracing phase when the brace is worn as prescribed for a 30-day trial period.



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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ability of parent/care giver to complete brace wear log/surveys in English
  2. Diagnosis of idiopathic clubfoot (unilateral or bilateral).
  3. Current use of the Ponseti SB with their Foot Abduction Brace.
  4. In the minimum 12-hour per day bracing stage of the Ponseti treatment
  5. 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).
  6. Well-corrected clubfoot/clubfeet (Pirani score ≤ 0.5)
  7. Enrollment in the SickKids Clubfoot Research Registry.

Exclusion Criteria:

  1. 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

  2. Current complaint of significant brace intolerance.
  3. 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.
  4. 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.
  5. The patient is using an older boot model, in which a temperature sensor cannot be inserted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293743


Contacts
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Contact: Maryse Bouchard 4168137654 ext 224522 maryse.bouchard@sickkids.ca
Contact: Hannah Seatle 905-330-1703 hannah.seatle@sickkids.ca

Sponsors and Collaborators
The Hospital for Sick Children
Publications:
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.
SickKids Internal Document. CLUBFOOT FAO BAR OPTIONS June 2017 edited. 2017 June.
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.
Mitchell JR, inventor. Quick clip for a club foot device. United States patent US 20160113803A1. 2002 Jun 9.
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/.
iButtonLink Technology [Internet]. DS1922L-F5# Thermochron iButton 8K -40 to 85°C; [cited 2021 July 1] Available from: https://www.ibuttonlink.com/products/ds1922l.
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
Youtube [Internet]. Installing I-Button in Ponseti AFO; [cited 2021 July 1] Available from: https://www.youtube.com/watch?v=YACSbFn-lOA.
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.

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Responsible Party: Maryse Bouchard, Assistant Professor, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT05293743    
Other Study ID Numbers: 1000078967
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing this data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities