Clinical trial NCT02196311: Treatment Of Supracondylar Fractures Closed Reduction And Circular Ring External Fixation Versus Open Reduction and Internal Fixation
Official title: TREATMENT OF SUPRACONDYLAR FRACTURES IN ADOLESCENTS: CLOSED REDUCTION AND CIRCULAR RING EXTERNAL FIXATION VERSUS OPEN REDUCTION AND INTERNAL FIXATION
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Supracondylar Humerus Fractures
Keywords: Supracondylar humerus fractures, external fixation, open reduction, and internal fixation.
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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.

Primary outcomes:
measure: Range of motion (ROM), change is being assessed
timeFrame: Initial post-op (first return visit to clinic after surgery), 6 (+/-) weeks, 3(+/-) months, 6 months, 1 year, and 2 years
Secondary outcomes:
measure: Treatments, change is being assessed
timeFrame: Initial post-op, 6 weeks, 3 months, 6 months, 1 year, and 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Texas Children's Hospital & Baylor College of Medicine
name: Jaclyn F Hill, MD
role: PRINCIPAL_INVESTIGATOR
References: