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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
Sponsor:
Collaborators:
NuVasive
St. Louis University
Information provided by (Responsible Party):
Florida Orthopaedic Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Humeral Fractures Device: Humeral Compression/Distraction (CD) Nail Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 12 months ]
    Complication rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Florida Orthopaedic Institute
NuVasive
St. Louis University
Investigators
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Principal Investigator: Roy W Sanders, MD Florida Orthopaedic Institute
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Responsible Party: Florida Orthopaedic Institute
ClinicalTrials.gov Identifier: NCT02861495    
Other Study ID Numbers: 2001
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data at this time.
Keywords provided by Florida Orthopaedic Institute:
upper extremity fracture
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries