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Trial record 7 of 832 for:    Texas Children's Hospital | ( Map: United States )

Treatment Of Supracondylar Fractures Closed Reduction And Circular Ring External Fixation Versus Open Reduction and Internal Fixation

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ClinicalTrials.gov Identifier: NCT02196311
Recruitment Status : Unknown
Verified September 2016 by Jaclyn Hill, Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : July 22, 2014
Last Update Posted : September 28, 2016
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Jaclyn Hill, Baylor College of Medicine

Brief Summary:
Patients treated with circular external fixation will have better outcomes (as measured by range of motion (ROM), alignment, outcome surveys) than those treated with open reduction and internal fixation (ORIF).

Condition or disease
Supracondylar Humerus Fractures

Detailed Description:

The purpose of this study is to compare patients who undergo ORIF versus circular external fixation for supracondylar humerus fractures in children ages 12-18. We are asking parental permission to collect information about their child's injury, x-rays, obtain ROM measures, collect input from questionnaires, and review other medical information relating to the injury.

The study is NOT about randomizing subjects to treatment, rather we are asking permission to keep track of the decisions that are made about our population's treatment and how it impacts their recovery.

The eligibility criteria is subject's between 12 and 18 years, if supracondylar/periarticular humerus fracture needed operative fixation, and the fracture is unable to be treated with percutaneous skeletal fixation. Patients will be excluded if they have had a previous elbow injury, Osteogenesis imperfecta or another fragile bone disease, elbow stiffness from another cause, or any pre-existing arm weakness.

The outcome measures all enrolled subjects will complete are the QuickDASH and the Pediatric and Adolescent Outcomes Instruments (PODCI). The QuickDASH is a shortened version of the DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure which is intended to measure symptoms and functions in people with musculoskeletal disorders of the upper limb. The QuickDASH is valid and reliable and is used for clinical and research purposes. The PODCI is designed to assess patients overall health, pain and ability to participate in normal daily activities in patients under 19 years of age. We will only distribute both questionnaires to the subjects and we are not collecting parent perception.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TREATMENT OF SUPRACONDYLAR FRACTURES IN ADOLESCENTS: CLOSED REDUCTION AND CIRCULAR RING EXTERNAL FIXATION VERSUS OPEN REDUCTION AND INTERNAL FIXATION
Study Start Date : March 2014
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Supracondylar humerus fractures
We are looking to compare open reduction internal fixation versus circular external fixation for supracondylar humerus fractures.



Primary Outcome Measures :
  1. Range of motion (ROM), change is being assessed [ Time Frame: Initial post-op (first return visit to clinic after surgery), 6 (+/-) weeks, 3(+/-) months, 6 months, 1 year, and 2 years ]
    Assessing ROM (elbow flexion/extension) in the initial post-operative period and long-term follow-up is an important outcome measure since it correlated with the ability to perform certain tasks with the arm (e.g. reaching head to shampoo/brush hair, reaching mouth to eat, etc.) The visit time frame as outlined above reflects the visits a child would typically return to clinic after surgery for a supracondylar fracture. Every visit will have a threshold of a few weeks to allow the family to return to clinic. These visits are all after the surgery has been performed. For example, the first or initial visit is the first time the patient will return to the hospital after surgery. At this visit the potential participant will be presented with the study materials and given the opportunity to participate. Should the participant participate the visits in the time frame will occur at the give interval.


Secondary Outcome Measures :
  1. Treatments, change is being assessed [ Time Frame: Initial post-op, 6 weeks, 3 months, 6 months, 1 year, and 2 years ]
    Evaluating the various treatments for supracondylar humerus fractures, open reduction internal fixation and circular external fixation. The visit time frame as outlined above reflects the visits a child would typically return to clinic after surgery for a supracondylar fracture. Every visit will have a threshold of a few weeks to allow the family to return to clinic. These visits are all after the surgery has been performed. For example, the first or initial visit is the first time the patient will return to the hospital after surgery. At this visit the potential participant will be presented with the study materials and given the opportunity to participate. Should the participant participate the visits in the time frame will occur at the give interval.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Texas Children Hospital will undergo either an open reduction with internal fixation or a closed reduction and circular ring external fixation based on the operating surgeon's preference. We do not plan on randomizing or assigning patients that present to Texas Children's Hospital with a supracondylar humerus fracture. Children that consent to participate will strictly continue their follow-up with the physician that performed the surgery. Post-operative course will be noted, physical exam and x-rays followed and outcome surveys obtained and measured intervals.
Criteria

Inclusion Criteria:

  • 12 and 18 years old
  • Supracondylar/periarticular humerus fracture needed operative fixation
  • Fracture is unable to be treated with percutaneous skeletal fixation.

Exclusion Criteria:

  • Any previous elbow injury
  • Osteogenesis imperfecta or another fragile bone disease
  • Elbow stiffness from another cause
  • Any pre-existing arm weakness.

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): NCT02196311


Contacts
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Contact: Mary Riordan 832-822-3100

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jaclyn F Hill, MD         
Sub-Investigator: Howard Epps, MD         
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
Investigators
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Principal Investigator: Jaclyn F Hill, MD Texas Children's Hospital & Baylor College of Medicine

Additional Information:
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Responsible Party: Jaclyn Hill, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02196311     History of Changes
Other Study ID Numbers: H-34336
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Keywords provided by Jaclyn Hill, Baylor College of Medicine:
Supracondylar humerus fractures, external fixation, open reduction, and internal fixation.

Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries