NCT02861495

Humeral Compression/Distraction Device

Humeral Compression/Distraction (CD) Device Used for Fixation of Humeral Fractures

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Florida Orthopaedic Institute · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary end point will be the union rate without secondary procedures. The hypothesis is that with the compression and distraction that this device makes possible, the investigators can achieve a higher union rate than with other forms of treatment, using a percutaneous approach, with a decreased complication rate, and can dynamically modulate the healing response when needed. The primary safety endpoint is the occurrence of adverse events from the time of treatment. During the healing process an external remote controller (ERC) will be used to continually compress or distract the fracture as needed. The surgeon will monitor healing and decide, clinically based on sequential radiographs during subsequent office visits, whether the fracture needs additional compression or distraction, an accordion technique, or no additional external manipulation via the ERC. Participants will be followed for 12 months.

Conditions

• Humeral Fractures

Interventions

Type	Name	Description
DEVICE	Humeral Compression/Distraction (CD) Nail	Surgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant

Timeline

• Start date: 2016-09-30
• Primary completion: 2018-08-09
• Completion: 2018-08-15
• First posted: 2016-08-10
• Last updated: 2018-09-07

Locations

1 site across 1 country: United States