Humeral Compression/Distraction Device

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

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.

Study Overview

• Status: Terminated
• Conditions: Humeral Fractures
• Intervention / Treatment: Device: Humeral Compression/Distraction (CD) Nail

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Complication rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.	12 months
Adverse Events	Adverse event rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.	12 months

Collaborators and Investigators

• Sponsor: Florida Orthopaedic Institute
• Collaborators: NuVasive; St. Louis University
• Investigators: Principal Investigator: Roy W Sanders, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2016
• Primary Completion (ACTUAL): August 9, 2018
• Study Completion (ACTUAL): August 15, 2018

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (ESTIMATE): August 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: upper extremity fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: 2001 (Other Grant/Funding Number: Waste Connections INC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share data at this time.