Intramedullary nailing of diaphyseal humeral fractures: T2™ humeral nail versus Fixion® intramedullary humeral nail
| ISRCTN | ISRCTN00265392 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00265392 |
| Secondary identifying numbers | NL923 (NTR947) |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.W. Gosler
Scientific
Scientific
Atrium Medisch Centrum
Department of Surgery/Afdeling Chirurgie
P.O. Box 4446
Heerlen
6401 CX
Netherlands
| Phone | +31 (0)45 5766599 |
|---|---|
| FixionNailStudy@gmail.com |
Study information
| Study design | Randomised, single blinded, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Intramedullary nailing of diaphyseal humeral fractures: T2™ humeral nail versus Fixion® intramedullary humeral nail |
| Study acronym | H-FINSS (Humeral - Fixion Intramedullary Nailing System Study) |
| Study objectives | 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(s) | Ethics approval pending from the local ethics committee (Medisch Ethische Toetsingscommissie AtriumMC - Maaslandziekenhuis) as of 30/05/2007. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2007 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 120 |
| Key inclusion criteria | Human volunteers with a minimal age of 18 years old with a humeral shaft fracture. |
| Key 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 |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Atrium Medisch Centrum
Heerlen
6401 CX
Netherlands
6401 CX
Netherlands
Sponsor information
Atrium Medical Centre (Atrium Medisch Centrum) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 4446
Heerlen
6401 CX
Netherlands
| Website | http://www.atriummc.nl/ |
|---|---|
"ROR" |
https://ror.org/0367sye10 |
Funders
Funder type
Hospital/treatment centre
Atrium Medical Centre (Atrium Medisch Centrum) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
