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

Supracondylar Humerus Fractures Clinical Trial

Official title:

TREATMENT OF SUPRACONDYLAR FRACTURES IN ADOLESCENTS: CLOSED REDUCTION AND CIRCULAR RING EXTERNAL FIXATION VERSUS OPEN REDUCTION AND INTERNAL FIXATION

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02196311
• Other study ID #: H-34336
• Status: Withdrawn
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Supracondylar Humerus Fractures

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion (ROM), change is being assessed	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.	Initial post-op (first return visit to clinic after surgery), 6 (+/-) weeks, 3(+/-) months, 6 months, 1 year, and 2 years
Secondary	Treatments, change is being assessed	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.	Initial post-op, 6 weeks, 3 months, 6 months, 1 year, and 2 years

External Links

•   Texas Children's Hospital - Orthopedics Department