To determine the amount of rotational instability in trochanteric femoral fractures, related to type of implant and fracture.The primary goal is to evaluate differences in fracture micromotion (i.e. translation and rotation) between different…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rotation and translation as determined on RSA radiographs in relation to type
of implant used: intra-, or extra-medullary.
Secondary outcome
Micromotion in relation to the position of the femoral head screw and bone
density. Local adverse events (cut-out, implant failure)
Background summary
Several fixation devices have been developed for treatment of proximal femur
fractures.
Still, treatment of these fractures suffers from relatively high complication
rates.
For treatment of trochanteric fractures extramedullary sliding hip screw
devices (e.g. DHS) and intramedullary nail fixations (e.g. Gamma-nail) are
commonly used.
Both types of implant are related to complications like cut-out of the implant,
nonunion and malunion.
Some of these complications may be accounted for by the induction of rotation
and/or translation of the femoral head-trochanter fragment.
Study objective
To determine the amount of rotational instability in trochanteric femoral
fractures, related to type of implant and fracture.
The primary goal is to evaluate differences in fracture micromotion (i.e.
translation and rotation) between different implants.
The secondary goal is to relate the micromotion to bone density (Dexa scans),
the position of the femoral head screw(s), the type of implant used, and the
type of fracture.
Study design
Sixty patients with an AO31-A2 type trochanteric fracture will be randomly
allocated to treatment with either DHS or Gamma-nail. RSA radiographs are
obtained postoperatively, on the first day, after 6 weeks, 4 months and one
year. One dexa scan will be obtained within 6 weeks postoperatively.
Study burden and risks
The burden and risk associated with extra radiographs and the insertion of the
tantalum beads of 0.5 mm diameter, used for RSA. Radiation risks are minimal
and should be regarded in the context of the generally high age of this patient
population. Normal X-ray protocol after a hip fracture is performed
postoperatively, at 6 weeks, 4 months, and on indication at 1 years. Patients
might benefit from the extended radiological examination and RSA during their
follow up. In patients that are diagnosed with osteoporosis, treatment will be
started.
Lijnbaan 32
2512 VA Den Haag
NL
Lijnbaan 32
2512 VA Den Haag
NL
Listed location countries
Age
Inclusion criteria
age over 60 year
AO31-A2 type trochanteric fracture
informed consent
Exclusion criteria
age under 60 year
AO31-A1 or A3 type trochanteric fracture
no informed consent
severe arthritis of the involved hip
reumatoid arthritis
pathological fracture
pre-existent immobility
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 7771 |
CCMO | NL30533.058.09 |