An observational study in Supracondylar Humerus Fractures, sponsored by Baylor College of Medicine. Withdrawn at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by Baylor College of Medicine · Observational
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).
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
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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.
Exclusion Criteria:
We are looking to compare open reduction internal fixation versus circular external fixation for supracondylar humerus fractures.
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.
Time frame: Initial post-op (first return visit to clinic after surgery), 6 (+/-) weeks, 3(+/-) months, 6 months, 1 year, and 2 years
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.
Time frame: Initial post-op, 6 weeks, 3 months, 6 months, 1 year, and 2 years
This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine