Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000992000
Ethics application status
Approved
Date submitted
14/11/2010
Date registered
16/11/2010
Date last updated
16/11/2010
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
nil
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
Fractures

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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
perioperative
Primary outcome [3] 259662 0
transfusion rate: it is accessed by count
Timepoint [3] 259662 0
perioperative
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
prospective, randomized
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3044 0
China
State/province [1] 3044 0

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

Ethics approval
Ethics application status
Approved

Summary
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

Contacts
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
China
Phone 15158 0
+86-13750835297
Fax 15158 0
Email 15158 0
[email protected]
Contact person for scientific queries
Name 6086 0
Zhao Xiang
Address 6086 0
Jiefang Road 88#, Hangzhou, Zhejiang,310009
Country 6086 0
China
Phone 6086 0
+86-13750835297
Fax 6086 0
Email 6086 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSurgical interventions for treating extracapsular hip fractures in older adults: A network meta-analysis.2022https://dx.doi.org/10.1002/14651858.CD013405
N.B. These documents automatically identified may not have been verified by the study sponsor.