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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
locking plate for treatment of intertrochanteric hip fractures
Scientific title
A prospective,randomised, controlled trial to evaluate the effect of locking plates compared with gamma nails on individuals with intertrochanteric hip fractures
Secondary ID [1] 253084 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intertrochanteric hip fractures 258648 0
Condition category
Condition code
Injuries and Accidents 258786 258786 0 0

Study type
Description of intervention(s) / exposure
Locking plate have recently been developed for the internal fixation of fractures, and are gaining widespread acceptance. This technique includes a plate and several screws. These screws can be locked in the plate. Locking plates have several advantages over traditional screw/plate constructs. There is improved angular stability because each screw acts as a small fixed-angled device. One can thus obtain better fixation in osteoporotic bone, and there is the opportunity to use unicortical, rather than bicortical screws.The locking plate is widely used in clinical practice, but is rarely used for intertrochanteric fracture in this study. It is applied in the operation for just once. The whole process would be completed during the operation, taking about 1 hour.
Intervention code [1] 257603 0
Treatment: Surgery
Comparator / control treatment
The gamma nail is an implant specifically designed for the fixation of intertrochantric and subtrochantric femoral fractures. It is inserted into the pulp cavity along the axis of the femoral bone and is fixed by screws. Now it is considered to be the comparablely better treatment for intertrochanteric fracture. In this study, we set it as control group. It is applied and completed just once during the operation, taking about 1 hour.
Control group

Primary outcome [1] 259653 0
incision length: it is accessed by the ruler
Timepoint [1] 259653 0
during the operation
Primary outcome [2] 259661 0
transfusion volume: It is accessed by count
Timepoint [2] 259661 0
Primary outcome [3] 259662 0
transfusion rate: it is accessed by count
Timepoint [3] 259662 0
Secondary outcome [1] 266324 0
radiological image: it is accessed by X-ray to determine the healing of the fractrue, the position of the locking plate or gamma nail, and the para position at the fracture side.
Timepoint [1] 266324 0
1 week after the operation, 3 month after the operation, 6 month after the operation
Secondary outcome [2] 266347 0
functional score: it is accessed by Harris hip score
Timepoint [2] 266347 0
1 week after the operation, 3 month after the operation, 6 month after the operation
Secondary outcome [3] 266348 0
range of movement: it is accessed by conimeter
Timepoint [3] 266348 0
1 week after the operation, 3 month after the operation, 6 month after the operation

Key inclusion criteria
1. primary intertrochanteric hip fracture only
2. BMI<30
3. no other disease that would affect the outcome of fractrue healing
4. no other previous surgical treatments
Minimum age
18 Years
Maximum age
100 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. BMI > 30
2. the patients that received previous other surgical treatment
3. the health condition is not stable
4. with other diaease that would affect bone healing, such as cancer, kidney disease needs corticosteroids

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes containing treatment assignment was prepared by a research assistant who was not involved in the study, and allocation to participants was applied in sequential order by another person that was not involved in the study either.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated with computer by one person that was not involved in this study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
prospective, randomized
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3044 0
State/province [1] 3044 0

Funding & Sponsors
Funding source category [1] 258052 0
Self funded/Unfunded
Name [1] 258052 0
Address [1] 258052 0
Country [1] 258052 0
Primary sponsor type
Zhao Gangsheng
Jiangdong Road 255#, Yiwu, Zhejiang, 322000
Secondary sponsor category [1] 257244 0
Name [1] 257244 0
Yan Shigui
Address [1] 257244 0
Jiefang Road 88#, Hangzhou, Zhejiang, 310009
Country [1] 257244 0
Secondary sponsor category [2] 257245 0
Name [2] 257245 0
Zhao Xiang
Address [2] 257245 0
Jiefang Road 88#, Hangzhou, Zhejiang, 310009
Country [2] 257245 0

Ethics approval
Ethics application status

Brief summary
Intertrochanteric fractures are common nowadays. Though there are several methods described in the literature for this kind of fracture, the optimal one is still in controversy. Gamma was considered to be a good choice for intertrochanteric hip fractrues, but it still has many limitations such as cracking the lateral trochanter. The locking plate was used to treat some other fractures such as distal femoral fracture. In recent days, some specialists proposed that locking plate could be used for intertrochanteric fractures. Now some mechanical test has confirmed it in laboratory.
This study attempts to determine whether locking plates can achieve an equal or better outcome compared with gamma nails for intertrochanteric hip fractures.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31911 0
Address 31911 0
Country 31911 0
Phone 31911 0
Fax 31911 0
Email 31911 0
Contact person for public queries
Name 15158 0
Zhao Xiang
Address 15158 0
Jiefang Road 88#, Hangzhou, Zhejiang, 310009
Country 15158 0
Phone 15158 0
Fax 15158 0
Email 15158 0
Contact person for scientific queries
Name 6086 0
Zhao Xiang
Address 6086 0
Jiefang Road 88#, Hangzhou, Zhejiang,310009
Country 6086 0
Phone 6086 0
Fax 6086 0
Email 6086 0

No information has been provided regarding IPD availability
Summary results
No Results