Humeral Compression/Distraction Device

NCT02861495 | Terminated

• 1 other identifier: 2001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Humeral Fractures

Keywords

upper extremity fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complication rate

  12 months

• Adverse Events

  12 months

Study Arms (1)

humeral nail

EXPERIMENTAL

Surgical fixation with a humeral compression/distraction nail.

Device: Humeral Compression/Distraction (CD) Nail

Interventions

Humeral Compression/Distraction (CD) Nail DEVICE

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

humeral nail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Orthopaedic Institute: lead
• NuVasive: collaborator
• St. Louis University: collaborator

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Roy W Sanders, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 10, 2016
• Study Start: September 30, 2016
• Primary Completion: August 9, 2018
• Study Completion: August 15, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)