The purpose of this study is to investigate whether Gamma3 intramedullary nails versus sliding hip screws will improve quality of life in patients with intertrochanteric fractures (hip fractures). We will also compare functional recovery,…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Health Related Quality of Life
To assess the impact of Gamma3 intramedullary nails versus sliding hip screws
on health-related quality of life as measured by the EuroQol-5D at 52 weeks
Secondary outcome
Health Related Quality of Life
health-related quality of life as measured with the Parker mobility score and
the Harris Hip Score.
Fracture healing rates
A fracture is to be considered healed when there is obliteration of the
fracture lines by newly formed bone along the cortices and within the
trabecular bone on anteroposterior and lateral (or oblique) radiographs.
Fracture-related adverse events
Including mortality, femoral shaft fracture, avascular necrosis (although rare
in trochanteric fractures), nonunion, malunion (shortening, varus deformity,
valgus deformity and rotational malunion), implant breakage or failure, and
infection (i.e., superficial and deep).
Revision surgery rates
Background summary
the current literature provides conflicting evidence of which implant (the
Gamma intramedullary nail versus the sliding hip screw) improves quality of
life and has a lower revision surgery and complication rate. The small sample
sizes, methodological limitations, and nonsignificant
pooled estimate from the direct comparisons, leave the issue very much in
doubt.
Study objective
The purpose of this study is to investigate whether Gamma3 intramedullary nails
versus sliding hip screws will improve quality of life in patients with
intertrochanteric fractures (hip fractures). We will also compare functional
recovery, complications, fracture healing, and rates of revision surgeries
between the two treatment groups.
Study design
a multi-center, concealed randomized controlled trial.
Intervention
Gamma3 Intramedullary Nails versus Sliding Hip Screws
Study burden and risks
Patients must fill in extra questionnaires at 4 moments. This will take maximum
60 minutes.
Moreover 1 extra clinical follow up is planned on 6 months (none X-ray).
Remaining follow up visit are according to standard care.
Beside this extra burden, there is no additional risk by participation in the
trial (regular risks of operation)
Stryker Trauma GmbH, Prof.-Kuentscher-Str. 1-5
Schoenkirchen/ Kiel 24232
DE
Stryker Trauma GmbH, Prof.-Kuentscher-Str. 1-5
Schoenkirchen/ Kiel 24232
DE
Listed location countries
Age
Inclusion criteria
1. Adult men or women aged 18 years and older (with no upper age limit).
2. A trochanteric fracture (stable or unstable) confirmed with anteroposterior and lateral hip
radiographs, computed tomography, or magnetic resonance imaging (MRI).
3. Low energy fracture (defined as a fall from standing height).
4. No other major trauma.
5. Patient was ambulatory prior to fracture, though they may have used an aid such as a
cane or a walker.
6. Anticipated medical optimization of the patient for operative fixation of the proximal
femur.
7. Operative treatment within 7 days after the trauma*.
8. Provision of informed consent by patient or proxy.
*Operative treatment should take place as soon as possible as permitted by each
institution*s standard of care.
Exclusion criteria
1. Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral
fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip).
2. Retained hardware rond de aangedane proximale femur.
3. Infection around the proximal femur (i.e., soft tissue or bone).
4. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget*s
disease, renal osteodystrophy, or osteomalacia).
5. Patients with Parkinson*s disease severe enough to increase the likelihood of falling or
severe enough to compromise rehabilitation.
6. Patients with a subtrochanteric fracture.
7. Patients with a pathologic fracture.
8. Patients with a reverse oblique fracture pattern.
9. Obesity in the judgment of the attending surgeon.
10. Off-label use of the implant.
11. Patients with a previous history of frank dementia that would interfere with assessment
of the primary outcome (i.e., EQ-5D at 1 year).
12. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will,
for example, exclude patients with no fixed address, those who report a plan to move out
of town in the next year, or intellectually challenged patients without adequate family
support.
13. Patient is enrolled in another ongoing drug or surgical intervention trial.
14. If the attending surgeon believes that there is another reason to exclude this patient from
INSITE. This reason will be documented on the case report forms.
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT01380444 |
| CCMO | NL40846.100.12 |