To determine the amount of in fracture micromotion (i.e. rotation and translation) in femoral neck fractures, related to type of used implant: a DHS or 3 cannulated hip screws.The secondary objective is to relate the micromotion to bone density, and…
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: DHS or 3 cannulated hip screws.
Secondary outcome
The amount of micromotion in relation to the position of the femoral head
screw(s). 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 femoral neck fractures there is a choice
between fixation with preservation of the head or without preservation of the
head. In case of preference for preservation of the head one can choose either
a fixation with the sliding hip screw devices (e.g. Dynamic Hip Screw (DHS)) or
with cannulated hip screws. Both implants are related to complications like
cut-out of the femoral head screw(s), non-union and malunion. Some of these
complications may be accounted for by the induction of rotation and translation
of the femoral head fragment.
Study objective
To determine the amount of in fracture micromotion (i.e. rotation and
translation) in femoral neck fractures, related to type of used implant: a DHS
or 3 cannulated hip screws.
The secondary objective is to relate the micromotion to bone density, and the
position of the femoral head screw(s).
Study design
Sixty patients with non-displaced femoral neck fractures (Garden type 1 or 2)
will be randomly allocated to treatment with either DHS or 3 cannulated hip
screws. RSA radiographs are obtained postoperatively, on the first day, after 6
weeks, 4 months and one year. A dexa scan will be acquired within 6 weeks after
fracture fixation.
Study burden and risks
The tantalum beads used with RSA are non-toxic and are not known to be
associated to any burden or risk. Radiation risks (280 µSv in conventional hip
X-rays versus 150 µSv in RSA X-rays) are minimal and should be regarded in the
context of the generally high age of this patient population. Besides the
RSA-measurements, all patients will be invited to a normal postoperative follow
up protocol. Patients might benefit from the extended (radiological)
examination during their follow up. A dexa scan is associated with 40 µSv. In
patients that are diagnosed with osteoporosis, treatment will be started.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
- Aged over 60 years
- Impacted/non-displaced femoral neck fracture, Garden 1-2
- Informed consent
Exclusion criteria
- Aged under 60 years
- Displaced femoral neck fracture, Garden 3-4
- Severe arthritis of the involved hip
- Rheumatoid arthritis
- Pathological fracture
- Pre-existent immobility
- No informed consent
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 | 7857 |
| CCMO | NL31156.058.10 |