Plating of Humeral Shaft Fractures in Multiple Trauma Patients. (NCT00720681) | Clinical Trial Compass
CompletedNot Applicable
Plating of Humeral Shaft Fractures in Multiple Trauma Patients.
96 participantsStarted 2008-08
Plain-language summary
The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age \> 18 years
* patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF)
* patients for whom the above fracture has healed
* patients willing and able to provide informed consent and able to participate in study procedures
Exclusion Criteria:
* patients with known pathological fractures
* patients with metabolic bone disease
* patients with humeral head or inter-articular surface fractures, or other upper extremity fractures
* patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.)
* patients with neurologic injury to upper extremities
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DASH (Disabilities of the Arm, Shoulder and Hand) Score
Timeframe: At Enrollment
2
Strength of injured arm compared to uninjured arm
Timeframe: At enrollment
3
Range of motion in injured arm compared to uninjured arm