Condition category
Musculoskeletal Diseases
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
30/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.atriummc.nl/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes