Humeral Compression/Distraction Device
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|ClinicalTrials.gov Identifier: NCT02861495|
Recruitment Status : Terminated (Study stopped due to low enrollment.)
First Posted : August 10, 2016
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Humeral Fractures||Device: Humeral Compression/Distraction (CD) Nail||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Humeral Compression/Distraction (CD) Device Used for Fixation of Humeral Fractures|
|Actual Study Start Date :||September 30, 2016|
|Actual Primary Completion Date :||August 9, 2018|
|Actual Study Completion Date :||August 15, 2018|
Experimental: humeral nail
Surgical fixation with a humeral compression/distraction nail.
Device: Humeral Compression/Distraction (CD) Nail
Surgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant
- Union rate [ Time Frame: 3 months post operatively ]Union rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.
- Complication rate [ Time Frame: 12 months ]Complication rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.
- Adverse Events [ Time Frame: 12 months ]Adverse event rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861495
|United States, Florida|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Roy W Sanders, MD||Florida Orthopaedic Institute|