Comparison of Braces for Treatment of Sever's Disease

NCT03494647 | Completed Results FDA Device

• 1 other identifier: 17-0611
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to learn more about braces that may help young athletes diagnosed with Sever's disease. Young athletes with this diagnosis who are seen by a Sports Medicine doctor will be asked it they want to be a part of the study. Patients who want to be in the study will be randomly assigned to wear one of two kinds of braces to treat their foot pain via randomization scheme independently created by a statistician. The subjects will be given the brace for free. The subjects will also answer survey questions about the brace when they first see the doctor, then at one, two, and three months after their first visit. Data collected in this study will help doctors gain a better understanding of how to treat young athletes who do sports without shoes who are diagnosed with Sever's disease.

Conditions

Sever's Disease

Outcome Measures

Primary Outcomes (1)

• Changes in the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) Scores

  The OxAFQ-C is used to measure subjective well-being for child patients (aged 5-16) affected by foot and ankle conditions using issues that are considered important to children. There are three domains to the OxAFQ-C: physical, school and play, and emotional well-being. The investigators will calculate the difference in OxAFQ-C Scores which range from 0 to 100 with higher scores indicating better functioning and higher well-being.

  Baseline and 3 months

Secondary Outcomes (1)

• Changes in the Visual Analog Scale Pain Score

  Baseline and 3 months

Study Arms (2)

Cheetah Heel Cup

ACTIVE COMPARATOR

Subjects randomly assigned to this group will receive the Cheetah Heel Cup at their initial visit.

Device: Cheetah Heel Cup

The X Brace

ACTIVE COMPARATOR

Subjects randomly assigned to this group will receive the X Brace at their initial visit.

Device: The X Brace

Interventions

Cheetah Heel Cup DEVICE

The Cheetah Heel Cup is composed of a rubber waffle that cups the athlete's heel, secured in place by a neoprene sleeve.

Cheetah Heel Cup

The X Brace DEVICE

The X Brace is composed of one thick elastic band that is wrapped around the athlete's arch of the foot. A second band is wrapped around the back of the heel, crossed under the foot, and secured to the thicker band on the bottom of the foot.

The X Brace

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-14 years
• Participate in barefoot sports including: martial arts, dance, gymnastics, or acrobatics
• Clinical diagnosis of Sever's or calcaneal apophysitis

You may not qualify if:

• History of foot/ankle surgery
• History of rheumatologic diagnoses
• Prisoners,
• pregnant females,
• Individuals with limited decision-making capacity

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Results Point of Contact

• Title: Emily Sweeney, MD
• Organization: Children's Hospital Colorado

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Emily A Stuart, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 11, 2018
• Study Start: April 18, 2018
• Primary Completion: November 21, 2021
• Study Completion: November 21, 2021
• Last Updated: May 25, 2022
• Results First Posted: May 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)