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Observational Safety Follow-Up of Pediatric Implants

Evaluating Implants for Pediatric Bone Healing</h2>\r\n<p>The purpose of this study is to evaluate the safety and efficacy (how well they do their job) of OrthoPediatrics medical implants used for specific orthopedic surgical procedures to treat hip conditions, fractures, and limb differences. Implants play a role in maintaining alignment and promoting healthy bone healing.</p>\r\n"}} id=text-a57b088283 class=cmp-text>

Evaluating Implants for Pediatric Bone Healing

The purpose of this study is to evaluate the safety and efficacy (how well they do their job) of OrthoPediatrics medical implants used for specific orthopedic surgical procedures to treat hip conditions, fractures, and limb differences. Implants play a role in maintaining alignment and promoting healthy bone healing.

Study Location | Status</h2>\r\n<p>91´óÉñ Children’s Health, Delaware | <b>Enrolling</b><br>\r\n&nbsp;</p>\r\n<h2>Participant&nbsp;Eligibility</h2>\r\n<p>Clinical trials have inclusion and exclusion requirements that determine eligibility. Key requirements are listed below. Please note there may be additional qualifications.</p>\r\n<p><b>Participants must be/have:</b></p>\r\n<ul>\r\n<li>Ages newborn to 25 years old.&nbsp;</li>\r\n<li>Require a specific implant placed during surgery.</li>\r\n</ul>\r\n<h2><br>\r\nAbout the Study</h2>\r\n<p><b>Formal Study Name:&nbsp;</b>Prospective Observational Implant Safety &amp; Efficacy Clinical Follow-Up Program</p>\r\n<p><b>Study Type: </b>Observational&nbsp;(researchers observe and record without intervening)</p>\r\n<p><b>Study ID:&nbsp;</b>2020421</p>\r\n<p><b>Sponsor/Coordinating Site:&nbsp;</b>University of British Columbia, OrthoPediatrics<b></b></p>\r\n<p><b>Start Date:&nbsp;</b>January 2022<b></b></p>\r\n<p><b>Completion Date:&nbsp;</b>December 2028<br>\r\n&nbsp;</p>\r\n<h2>What’s Involved</h2>\r\n<p>Investigators will collect and analyze information about a participant’s condition, surgery, bone healing, X-rays, and any complications that might arise.&nbsp;</p>\r\n<p>The participant will be asked to complete questionnaires related to the treatment. Most participants will be in the study for approximately 6 months to 2 years.</p>\r\n<p>The number of visits and X-rays is standard of care as determined by the treating surgeon. No extra visits or X-rays are done as part of the study. Participants will be asked to complete surveys approximately every 3 to 6 months while they are in the study.</p>\r\n"}} id=text-63a360b8c6 class=cmp-text>

Study Location | Status

91´óÉñ Children’s Health, Delaware | Enrolling
Ìý

ParticipantÌýEligibility

Clinical trials have inclusion and exclusion requirements that determine eligibility. Key requirements are listed below. Please note there may be additional qualifications.

Participants must be/have:

  • Ages newborn to 25 years old.Ìý
  • Require a specific implant placed during surgery.


About the Study

Formal Study Name:ÌýProspective Observational Implant Safety & Efficacy Clinical Follow-Up Program

Study Type: ObservationalÌý(researchers observe and record without intervening)

Study ID:Ìý2020421

Sponsor/Coordinating Site:ÌýUniversity of British Columbia, OrthoPediatrics

Start Date:ÌýJanuary 2022

Completion Date:ÌýDecember 2028
Ìý

What’s Involved

Investigators will collect and analyze information about a participant’s condition, surgery, bone healing, X-rays, and any complications that might arise.Ìý

The participant will be asked to complete questionnaires related to the treatment. Most participants will be in the study for approximately 6 months to 2 years.

The number of visits and X-rays is standard of care as determined by the treating surgeon. No extra visits or X-rays are done as part of the study. Participants will be asked to complete surveys approximately every 3 to 6 months while they are in the study.

How This Study Fits in

This study reflects our broader commitment at 91´óÉñ to improve care through research. Clinical trials like this one are&nbsp;shaped by the expertise&nbsp;of our medical teams and research programs. Learn how related research and clinical care support, and are strengthened by, studies like this one.</p>\r\n"}} id=text-abf9244cac class=cmp-text>

This study reflects our broader commitment at 91´óÉñ to improve care through research. Clinical trials like this one areÌýshaped by the expertiseÌýof our medical teams and research programs. Learn how related research and clinical care support, and are strengthened by, studies like this one.

More About Clinical Trials

Learn what to expect from a clinical trial&nbsp;—&nbsp;how they work, why they matter, and what to consider when deciding if one is right for your child.</p>\r\n"}} id=text-e1520f0143 class=cmp-text>

Learn what to expect from a clinical trialÌý—Ìýhow they work, why they matter, and what to consider when deciding if one is right for your child.


Mom
Learn About Limb Lengthening Surgery From 91´óÉñ KidsHealth<sup>®</sup></h2>\r\n"}} id=text-42670c6540 class=cmp-text>

Learn About Limb Lengthening Surgery From 91´óÉñ KidsHealth®

Limb lengthening surgery with an external fixator is done to help correct a limb length discrepancy. With the right care and support, most kids recover well. Find out what to expect before, during, and after surgery from 91´óÉñ experts.</p>\r\n"}} id=text-16c6608f92 class=cmp-text>

Limb lengthening surgery with an external fixator is done to help correct a limb length discrepancy. With the right care and support, most kids recover well. Find out what to expect before, during, and after surgery from 91´óÉñ experts.