Humeral Compression/Distraction Device
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/9/2018 |
| Start Date: | September 30, 2016 |
| End Date: | August 15, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
1 Tampa General Cir
Tampa, Florida 33606
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Hassan Mir, MD
Phone: 813-253-2068
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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