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Trial registered on ANZCTR


Registration number
ACTRN12608000162314
Ethics application status
Not yet submitted
Date submitted
19/03/2008
Date registered
4/04/2008
Date last updated
25/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective Randomised Pilot Study Comparing The Dynamic Hip Screw and Intramedullary Gamma Nail Regarding The Treatment Of Intertrochanteric Hip Fracture
Scientific title
Prospective Randomised Pilot Study Comparing The Dynamic Hip Screw and Intramedullary Gamma Nail Regarding Functional Recovery Following The Treatment Of Intertrochanteric Hip Fracture
Universal Trial Number (UTN)
Trial acronym
dhsvsgamma1.0
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intertrochanteric Hip Fracture 2462 0
Condition category
Condition code
Musculoskeletal 3122 3122 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gamma 3 Trochanteric Nail:
The Gamma3 Short Intramedullary Nailing System was designed to facilitate minimally invasive surgery and reduce Operation time down to a minimum by the aid of using new instrumentation and an optimized surgical technique. The nails have a proximal diameter of 15.5mm to help minimize the incision length required for minimally invasive surgery. The Gamma3 nail offers the same biomechanical strength and cutout resistance as the well established Trochanteric and Long Gamma Nails. The new lag screw shape has been improved in the area of the thread and the cutting flutes at the tip of the screw. The new design offers superior cutting behavior during lag screw insertion, providing low insertion torque. The new thread design offers grip in the cancellous bone of the femoral head and strong resistance against cut out. The 5mm distal locking screws are currently used in the Gamma-Ti and T2 intramedullary nailing systems.
The gamma nail system will remain in the patients femur permanently.This is a once off treatment
Intervention code [1] 2716 0
Treatment: Devices
Comparator / control treatment
Dynamic Hip Screw:
Compared to other hip implants, the Dynamic hip screw is technically easy to insert. It is designed to transfer some of the load onto the bone, differentiating it from rigid implants that bear the entire load and are thus more in danger of breaking. The gliding mechanism of the dynamic hip screw to a large extent prevents the implant from perforating the acetabulum if the fracture zone slips under stress. The dynamic hip screw principle is therefore a “load-sharing” rather than a “load-bearing” internal fixation. Pertrochanteric and intertrochanteric fractures of the type 31-A according to the American society of internal fixation classification are the major indications for the Dynamic hip screw. In extremely unstable fractures, additional implants such as the Dynamic hip screw Trochanter Stabilizing Plate or the Dynamic hip screw Locking Device may be necessary. It is also possible to perform a corrective trochanteric osteotomy using the Dynamic hip screw. For the treatment of lateral fractures of the femoral neck and Pertrochanteric fractures, the Dynamic hip screw is one of the most popular implants. This is also the case for Trochanteric fractures with subtrochanteric extension. These fractures are classified as trochanteric fractures and must be differentiated from purely subtrochanteric fractures with intact trochanteric zones.The dynamic hip screw will remain in the patient and is a once off treatment for intertrochanteric hip fracture.
Control group
Active

Outcomes
Primary outcome [1] 3467 0
Operative Data:
Surgical time,
Fluoroscopy time,
blood loss/ blood transfusion,
skin incision length
Timepoint [1] 3467 0
Surgery
Primary outcome [2] 4016 0
Post operative Data
Functional recovery score
Radiographic analysis:
amount of fracture collapse will be measured on standardized radiographs
Timepoint [2] 4016 0
discharge, 6 weeks, 3,6,12,24 months
Primary outcome [3] 4017 0
6 minute walk test
Timepoint [3] 4017 0
6 weeks and 6 months
Secondary outcome [1] 6629 0
Functional recovery through the use of a validated assessment tool: The Functional Recovery Score.
Timepoint [1] 6629 0
6 weeks, 3, 6, 12, and 24 months

Eligibility
Key inclusion criteria
A non pathological intertrochanteric hip fracture.
Fracture classified as association for osteosynthesis/orthopaedic trauma association (AO/OTA) 31-A1 or A2 or a stable fracture after reduction. Experienced a low-energy injury only.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Fracture classified as association for osteosynthesis/orthopaedic trauma association (AO/OTA) 31A-A3.
Unstable fracture after reduction.
A pathologic fracture.
A fracture associated with polytrauma.
Had previous ipsilateral hip or femur surgery.
A fracture with extension 5cm distal to the inferior border of the lesser trochanter.
An associated neurovascular injury with objective neurological findings on physical examination.
An inability to comply with follow up procedures (including inability to read and fill out forms).
A medical contraindication to surgery and or anesthesia (such as heart disease, renal failure or active chemotherapy).
Lack of consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment will be done by operating surgeon upon admission into hospital. Allocation will occur by operating surgeon contacting the holder of the allocation schedule which is to be kept on an "off-site" computer. Device type will only be known to surgeon, all other research staff blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3241 0
Self funded/Unfunded
Name [1] 3241 0
Rob Molnar
Country [1] 3241 0
Australia
Primary sponsor type
Individual
Name
Rob Molnar
Address
4 Short St
Kogarah New South Wales 2217
Country
Australia
Secondary sponsor category [1] 2867 0
Individual
Name [1] 2867 0
Rob Molnar
Address [1] 2867 0
4 Short St
Kogarah New South Wales 2217
Country [1] 2867 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5222 0
Royal Prince Alfred Hospital (RPAH) zone
Ethics committee address [1] 5222 0
Research Development Office
Level 8
Building 14
Royal Prince Alfred Hospital
Camperdown New South Wales 2050
Ethics committee country [1] 5222 0
Australia
Date submitted for ethics approval [1] 5222 0
01/02/2008
Approval date [1] 5222 0
Ethics approval number [1] 5222 0
Ethics committee name [2] 5223 0
Ethics committee address [2] 5223 0
Ethics committee country [2] 5223 0
Date submitted for ethics approval [2] 5223 0
01/02/2008
Approval date [2] 5223 0
Ethics approval number [2] 5223 0

Summary
Brief summary
Study Rationale:
The current choice of treatment for intertrochanteric fracture is the Dynamic Hip Screw. Technical and mechanical failure of this device currently occurs in 6-18% of all cases. Better understanding, more validated data and the need for better treatment regarding intertrochanteric fracture is necessary. "Prospective studies comparing the trochanteric nail, with and without distal interlocking to the sliding/dynamic hip screw are warranted".

Study Aim:
The purpose of this prospective randomised study is to compare the intramedullary gamma nail to the dynamic hip screw in regards to functional outcome.

Specific Aims:
The aim of this study is to compare the results of the surgical intervention with parameters such as operative time, blood loss, operative complications and cost for each device. In the post operative period the functional results of patients will be compared with initial mobilisation and discharge through to long term function and return to activities of daily living. The degree of fracture collapse will be recorded and compared to function. Long term fracture union will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28117 0
Address 28117 0
Country 28117 0
Phone 28117 0
Fax 28117 0
Email 28117 0
Contact person for public queries
Name 11274 0
Peter Cairns
Address 11274 0
4 Short St
Kogarah New South Wales 2217
Country 11274 0
Australia
Phone 11274 0
+61 2 95874720 Mobile: 0408615126
Fax 11274 0
Email 11274 0
[email protected]
Contact person for scientific queries
Name 2202 0
Rob Molnar
Address 2202 0
4 Short St
Kogarah New South Wales 2217
Country 2202 0
Australia
Phone 2202 0
+61 2 95874720 Mobile: 0402730732
Fax 2202 0
Email 2202 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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