Humeral Compression/Distraction Device

Humeral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02861495
• Other study ID #: 2001
• Status: Terminated
• Phase: N/A
• Start date: September 30, 2016
• Est. completion date: August 15, 2018

Study information

• Verified date: September 2018
• Source: Florida Orthopaedic Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 15, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

Intervention

Device:
• Humeral Compression/Distraction (CD) Nail
Surgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida Orthopaedic Institute	NuVasive, St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Union rate	Union rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.	3 months post operatively
Secondary	Complication rate	Complication rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.	12 months
Secondary	Adverse Events	Adverse event rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.	12 months