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Humeral Compression/Distraction Device

NCT02861495 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-09-07

No results posted yet for this study

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.

Conditions

  • Humeral Fractures

Interventions

DEVICE

Humeral Compression/Distraction (CD) Nail

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

Sponsors & Collaborators

  • NuVasive

    collaborator INDUSTRY

  • St. Louis University

    collaborator OTHER

  • Florida Orthopaedic Institute

    lead NETWORK

Principal Investigators

  • Roy W Sanders, MD · Florida Orthopaedic Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-08-09
Completion
2018-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02861495 on ClinicalTrials.gov