ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

intertrochanteric hip fractures

Condition category

Condition code

Injuries and Accidents

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]

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]

incision length: it is accessed by the ruler

Timepoint [1]

during the operation

Primary outcome [2]

transfusion volume: It is accessed by count

Timepoint [2]

perioperative

Primary outcome [3]

transfusion rate: it is accessed by count

Timepoint [3]

perioperative

Secondary outcome [1]

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]

1 week after the operation, 3 month after the operation, 6 month after the operation

Secondary outcome [2]

functional score: it is accessed by Harris hip score

Timepoint [2]

1 week after the operation, 3 month after the operation, 6 month after the operation

Secondary outcome [3]

range of movement: it is accessed by conimeter

Timepoint [3]

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?

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]

China

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

China

Primary sponsor type

Individual

Name

Zhao Gangsheng

Address

Jiangdong Road 255#, Yiwu, Zhejiang, 322000

Country

China

Secondary sponsor category [1]

Individual

Name [1]

Yan Shigui

Address [1]

Jiefang Road 88#, Hangzhou, Zhejiang, 310009

Country [1]

China

Secondary sponsor category [2]

Individual

Name [2]

Zhao Xiang

Address [2]

Jiefang Road 88#, Hangzhou, Zhejiang, 310009

Country [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Zhao Xiang

Address

Jiefang Road 88#, Hangzhou, Zhejiang, 310009

Country

China

Phone

+86-13750835297

Fax

dr.zhaoxiang@gmail.com

Contact person for scientific queries

Name

Zhao Xiang

Address

Jiefang Road 88#, Hangzhou, Zhejiang,310009

Country

China

Phone

+86-13750835297

Fax

dr.zhaoxiang@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Surgical interventions for treating extracapsular hip fractures in older adults: A network meta-analysis.	2022	https://dx.doi.org/10.1002/14651858.CD013405

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically