Intramedullary Nailing of Diaphyseal Humeral Fractures - T2? Humeral Nail versus Fixion ® Intramedullary Humeral Nail

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR947
• Date of registration: 08/04/2007
• Primary sponsor: Atrium Medisch Centrum Parkstad
• Public title: Intramedullary Nailing of Diaphyseal Humeral Fractures - T2? Humeral Nail versus Fixion ® Intramedullary Humeral Nail
• Scientific title: Intramedullary Nailing of Diaphyseal Humeral Fractures - T2? Humeral Nail versus Fixion ® Intramedullary Humeral Nail - H-FINSS (Humeral - Fixion Intramedullary Nailing System Study)
• Date of first enrolment: 1/5/2007
• Target sample size: 120
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=947
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: B. Meesters

• Name: M.W. Gosler

Key inclusion & exclusion criteria

Inclusion criteria: Human volunteers with a minimal age of 18 years old with a humeral shaft fracture.
Exclusion criteria: 1. Gustilo and Anderson classification III-C;
2. Primary bone disease:
a. Fibrous Dysplasia;
b. Gaucher's Disease;
c. Osteogenesis Imperfecta;
d. Osteomalacia;
e. Osteomyelitis;
f. Pagets Disease;
g. Renal Osteodystrophy;
3. Postoperative treatment in an hospital not participating in the study.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Fixion Nail , Humeral fractures, Intramedullary, Humerus , Expandable

Intervention(s)

The patient with the suspicion of a humeral shaft fracture will be examined at the first aid department and will be diagnosed with x-ray. In case of open fractures the wound will be brief inspected, applicated with a sterile dressings and administration of intravenous antibiotics. After the diagnose of a humeral shaft fracture the first aid doctor will check if the patient meets the inclusion- and exclusion criteria, if that's the cases, the patient will be informed about the study and will be asked to give informed consent. After informed consent is given the patient will be randomized in one of the two groups.
In the operating room a thorough wound debridement will be performed with excision of all devitalised soft tissue prior to nailing. Primary wound closure should normally not be performed. Small wounds will close by secondary intention and larger wounds should be covered by either split thickness skin grafts or, in case of bone exposure, a fasciocutaneous or a free vascular flap.
Implantation of intramedullary nails will be performed following the recommendations given in the instructional manuals of Stryker and Disc-O-Tech, and with the original materials provided by these companies. Proximal or distal locking has to be performed with one locking screws, depending on a retro- or antegrade insertion. Both intramedullary nailing devices are suitable for static fixation. Static fixation will be performed in complex and/or length unstable fractures. In case of any doubt on the stability of osteosynthesis, static fixation is recommended.
To assess adequate timing, the moment of skin incision, closure, and reduction time must be reported. Peri-operatively, fluoroscopy time will be recorded.



Quality of reduction is determined at the first postoperative X-ray; angulation (anterior/posterior or varus/valgus) and shortening (or lengthening) will be measured. Rotation will be measured by physical examination.

Primary Outcome(s)

The primary objective of the study is to investigate the peroperative fluoroscopic time.

Secondary Outcome(s)

Secondary objectives will be:
1. procedure time;
2. number of infections;
3. number of complications;
4. hospitalisation time;
5. resumption of full activities.

Secondary ID(s)

ISRCTN00265392

Source(s) of Monetary Support

Atrium Medisch Centrum Parkstad