Contact information
Type
Scientific
Primary contact
Dr M.W. Gosler
ORCID ID
Contact details
Atrium Medisch Centrum
Department of Surgery/Afdeling Chirurgie
P.O. Box 4446
Heerlen
6401 CX
Netherlands
+31 (0)45 5766599
FixionNailStudy@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
H-FINSS (Humeral - Fixion Intramedullary Nailing System Study)
Study hypothesis
Theoretically there are many advantages of using the Fixion® Intramedullary (IM) humeral nail, like a significant reduced surgical and fluoroscopic exposure time. The procedure is simple and minimally invasive. No interlocking screws are needed, thus there is a reduced risk of infection. Reaming becomes an optional procedure. Due to the abutment of the longitudinal bars along the entire length of the medullary canal walls, high resistance to the rotational forces is achieved. Removal will be easier as the nail is deflatable. The Fixion® Intramedullary Nail combines the advantages of unreamed nailing with regards to preservation of endosteal blood supply and the biomechanical advantages of reamed nailing due to the bone-nail contact. Postoperatively the arm is stable for practice and after six weeks stable for daily usage.
Ethics approval
Ethics approval pending from the local ethics committee (Medisch Ethische Toetsingscommissie AtriumMC - Maaslandziekenhuis) as of 30/05/2007.
Study design
Randomised, single blinded, active controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Humeral Fractures and Fixion® Intramedullary (IM) humeral nail
Intervention
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 briefly inspected, sterile dressings will be applied and intravenous antibiotics administered. After the diagnosis of a humeral shaft fracture the first aid doctor will check if the patient meets the inclusion and exclusion criteria, if that's the case, 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 randomised 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 screw, 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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary objective of the study is to investigate the perioperative fluoroscopic time.
Patients in the study will be assessed in the early postoperative period prior to discharge, at the trauma clinic at 3, 6, 12, 18, 24, 36 and 48 weeks post-trauma and in case of complications at least every four weeks. To achieve an adequate estimation on consolidation time, it is important to make check X-rays at every visit, until consolidation is achieved.
Secondary outcome measures
Secondary objectives will be:
1. Procedure time
2. Number of infections
3. Number of complications
4. Hospitalisation time
5. Resumption of full activities
Patients in the study will be assessed in the early postoperative period prior to discharge, at the trauma clinic at 3, 6, 12, 18, 24, 36 and 48 weeks post-trauma and in case of complications at least every four weeks. To achieve an adequate estimation on consolidation time, it is important to make check X-rays at every visit, until consolidation is achieved.
Overall trial start date
01/05/2007
Overall trial end date
01/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Human volunteers with a minimal age of 18 years old with a humeral shaft fracture.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
1. Gustilo and Anderson classification IIIC
2. Primary bone disease:
2.1. Fibrous dysplasia
2.2. Gaucher's disease
2.3. Osteogenesis imperfecta
2.4. Osteomalacia
2.5. Osteomyelitis
2.6. Pagets disease
2.7. Renal osteodystrophy
3. Postoperative treatment in an hospital not participating in the study
Recruitment start date
01/05/2007
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Atrium Medisch Centrum
Heerlen
6401 CX
Netherlands
Sponsor information
Organisation
Atrium Medical Centre (Atrium Medisch Centrum) (The Netherlands)
Sponsor details
P.O. Box 4446
Heerlen
6401 CX
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Atrium Medical Centre (Atrium Medisch Centrum) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list