Humeral Compression/Distraction Device
Stopped early · Not applicable
Conditions studied: Humeral Fractures
In brief
The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlled wirelessly by rare earth magnets, which typically offers distraction for lengthening. In the humerus however, during the treatment of acute fractures, this percutaneously inserted nail can also offer compression during the healing process, thereby negating the effect of gravity, which may in turn lead to a faster and more consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of the nail may employ an "accordion technique" (alternating compression-distraction, a feature unique to this implant.
Key facts
- Study ID
- NCT02861495
- Run by
- Florida Orthopaedic Institute
- People needed
- 2
- Starts
- 2016-09-30
- Expected to finish
- 2018-08-15
- Last updated by the study team
- 2018-09-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult skeletally mature patients 18 years or older, treated by the Orthopaedic Trauma Service at Tampa General Hospital, and the Trauma Service at St. Louis University Hospital
- Open or closed displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions or malunions
- amenable to treatment with an intramedullary nail
You may not qualify if…
- Intra-articular extension of the fracture, prohibiting treatment with an intramedullary nail;
- Pathologic fracture
- Retained hardware
- Patients with pacemakers
- Age under 18 years.
- Patients who are prisoners or likely to become prisoners
- Homeless, or those likely to have difficulty making follow-up appointments
- Pregnancy
- Ipsilateral nerve or vascular injuries
- Immunocompromised patients
Where it is running
- Tampa General Hospital — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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