The primary objective of this trial is to test if these favorable results with the DLBP can be upheld in a multicenter randomized controlled trial with patients up to 65 years with a displaced FNF. We hypothesize that the DLBP is superior compared…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of revision surgery after fixation of a displaced FNF treated with
DLBP or DHS due to non-union, AVN or cut out of the implant.
Secondary outcome
Incidence of avascular necrosis
Incidence of non-union
Incidence of implant related complications.
Post-operative complications
Rate of elective implant removal after union
Functional outcome
Operation time
Costs
Health related quality of life.
Background summary
In 1990 an estimated 1.66 million patients sustained a hip fracture worldwide.
This number has increased over time and is estimated to be 6 million in 2050
worldwide. Despite these numbers the optimal treatment of hip fractures is
still under debate. Especially the treatment of displaced femoral neck
fractures (FNF) differs worldwide. A general consensus is that young patients
(up to 65 years of age) should be treated with fracture reduction and internal
fixation. Nowadays the most commonly used implants are multiple cannulated
parallel screws and the dynamic hip screw (DHS). The DHS has a small advantage
over multiple parallel screws in displaced FNF. Despite the frequent use of
these implants the failure rate is still high, with a non-union rate of 30-33%
and an incidence of avascular necrosis of 10-16%. The reoperation rate lies
between the 18-48%. The Dynamic Locking Blade Plate (DLBP), otherwise called
*The Gannet*, is specifically designed for the surgical fixation of
intracapsular hip fractures. The characteristics of the DLBP are its low
implant volume, rotational stability, angular stability and its simple
instrumentation and surgical technique. In a prospective multicenter cohort
study in the Netherlands 172 patients with undisplaced FNF were treated with
the DLBP. The results of this study showed a failure rate of 4%. Another recent
prospective cohort of 114 patients of 60 years and younger with displaced FNF
demonstrated a DLBP related failure rate 13.2%.
The primary objective of this trial is to test if these favorable results with
the DLBP can be upheld in a multicenter randomized controlled trial with
patients up to 65 years with a displaced FNF. We hypothesize that the DLBP is
superior compared to the DHS in terms of revision surgery, union rate, AVN,
implant related failure, as well as functional outcome.
Study objective
The primary objective of this trial is to test if these favorable results with
the DLBP can be upheld in a multicenter randomized controlled trial with
patients up to 65 years with a displaced FNF. We hypothesize that the DLBP is
superior compared to the DHS in terms of revision surgery, union rate, AVN,
implant related failure, as well as functional outcome.
Study design
This is a multicenter unblinded randomized controlled trial with a superiority
design comparing two surgical procedures.
Intervention
One group will be treated with the Dynamic Locking Blade Plate. The other group
will be treated with Dynamic Hip screw (control group).
Study burden and risks
The additional burden for patients by participating in this study is minor. The
patients will be asked at five times to complete a questionnaire via internet
or by post. The patients will visit the outpatient clinics three times after
discharge. At least two of these visits will be routine follow-up visits after
treatment. Therefore this is potentially one extra follow up visit for other
reasons than the routine follow-up visits. The treatment will not differ from
the standard care of femoral neck fractures. Both implants that are used in
this study are CE-registered devices and commonly used in multiple hospitals in
the Netherlands and abroad.
Nico Bolkesteinlaan 75
Deventer 7416 SE
NL
Nico Bolkesteinlaan 75
Deventer 7416 SE
NL
Listed location countries
Age
Inclusion criteria
• 18- 65 years
• Displaced Femoral Neck Fracture (Garden type III or IV) 14
• Written informed consent
Exclusion criteria
Patients with:
• Pathological fracture.
• Ipsilateral or contralateral fractures of the lower extremity.
• Patients with an Injury Severity Score (ISS) of >=16.
• Local infection or inflammation.
• Symptomatic arthritis, diagnosed by a rheumatologist.
• Symptomatic osteoarthritis or radiographic osteoarthritis grade III or IV. 15
• Previous surgery to the ipsilateral hip.
• Inadequate tissue coverage.
• Morbid obesity (BMI >= 35).
• Patients who are wheelchair-bound.
• Patients who were, at the time of trauma, admitted to a nursing home.
• Patients who are not mentally competent
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 |
|---|---|
| CCMO | NL63529.075.18 |