ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000103662

Ethics application status

Approved

Date submitted

19/11/2022

Date registered

30/01/2023

Date last updated

30/01/2023

Date data sharing statement initially provided

30/01/2023

Date results provided

30/01/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Assessment of radiological healing in elderly hip fractures fixed with intramedullary versus extramedullary implants at 3 months

Scientific title

Assessment of radiological healing via radiological union score for hip (RUSH) score in elderly hip fractures fixed with intramedullary versus extramedullary implants at 3 months

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

elderly hip fractures

Condition category

Condition code

Injuries and Accidents

Fractures

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intramedullary implant. Implant which is inserted centrally into the bone by an orthopedic surgeon.Intramedullary implant used will be proximal femoral nail or gamma nail.
Extramedullary implants used will be either dynamic hip screw, dynamic condylar screw, cannulated screws, or proximal femoral locking plate.
The procedure time will be around 1 hour. Allocation will be up to the discretion of treating surgeon.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Extramedullary implants used will be either dynamic hip screw, dynamic condylar screw, cannulated screws, or proximal femoral locking plate
Implant which is placed eccentrically onto the bone. Intramedullary implant used will be proximal femoral nail or gamma nail. The procedure time will be around 1 hour. Allocation will be up to the discretion of treating surgeon.

Control group

Active

Outcomes

Primary outcome [1]

Radiological healing assessed using hip x-rays in accordance with the The Radiographic Union Score for Hip (RUSH) score'

Timepoint [1]

2 weeks post surgery, 6 weeks post surgery, 3 months post surgery (primary end-point), 6 months post surgery

Secondary outcome [1]

pain using visual analogue scale

Timepoint [1]

2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery

Eligibility

Key inclusion criteria

50 to 80 years old patients of both genders having hip fracture (Transcervical, Intertrochanteric and Subtrochanteric)

Minimum age

50 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Refusal of informed consent.
Unwilling/unable to comply with follow up.
Patients with polytrauma.
Patients taking steroids.
Patients taking immunosuppressants/DMARDs.
Patients with pathological fracture.
Patients unfit for surgery (ASA III and above).

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

1/12/2021

Date of last participant enrolment

Anticipated

Actual

31/05/2022

Date of last data collection

Anticipated

31/01/2023

Actual

Sample size

Target

238

Accrual to date

Final

238

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Lady Reading Hospital

Address [1]

street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa

Country [1]

Pakistan

Primary sponsor type

Government body

Name

Health Department Khyber Pakhtunkhwa

Address

street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa

Country

Pakistan

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Instituitional Review Board, Lady Reading Hospital

Ethics committee address [1]

street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

Approval date [1]

03/11/2020

Ethics approval number [1]

Summary

Brief summary

The rationale of this study is to address the knowledge gap in management of hip fracture and compare the radiological healing (assessed via RUSH score) at 3 months in patients with hip fracture managed with plates and nails. 
Hypothesis: There is a difference in radiological healing of hip fractures at 3 months fixed with either intramedullary or extramedullary implants.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr syed imran bukhari

Address

Lady Reading Hospital, street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa

Country

Pakistan

Phone

+923339630619

Fax

[email protected]

Contact person for public queries

Name

syed imran bukhari

Address

Syed Imran Bukhari, street 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa

Country

Pakistan

Phone

+923339630619

Fax

[email protected]

Contact person for scientific queries

Name

syed imran bukhari

Address

Syed Imran Bukharistreet 2, Soi Karno chowk, Peshawar, 25000, Khyber Pukhtunkhwa

Country

Pakistan

Phone

+923339630619

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

local policies do not allow

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17662	Ethical approval					385011-(Uploaded-19-11-2022-03-16-38)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Current Study Results

Documents were uploaded by study researchers but have since been removed.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4175	Plain language summary	Yes	https://doi.org/10.35845/kmuj.2023.23046	Out of 238 patients, 96 were males and 142 were fe... [More Details]	23046-RUSH_Manuscript.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically