ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000160538

Ethics application status

Not yet submitted

Date submitted

1/05/2006

Date registered

5/05/2006

Date last updated

5/05/2006

Type of registration

Prospectively registered

Titles & IDs

Public title

Aggressive mobilisation following fragment specific fixation of distal radius fractures

Scientific title

Aggressive mobilisation following fragment specific fixation of distal radius fractures improves functional outcome of the wrist joint

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Distal radial fractures

Condition category

Condition code

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Aggressive physiotherapy is the intervention group. From day 1 post operatively they will receive intense encouragement both active and passive to achieve increased range of motion and grip strength. Both will attend 1-3 sessions per week with encouragement to do home exercises. Treatment will be for 6 months

Intervention code [1]

Rehabilitation

Comparator / control treatment

Regular physiotherapy is the control group. They will receive a more moderate form of the aggressive regime.

Control group

Active

Outcomes

Primary outcome [1]

Function of the wrist joint. We will use specific wrist scores "The Functional Index" (FI) and "Patient Rated Wrist Evaluation" (PRWE).

Timepoint [1]

Tested at 6 weeks, 3 months, and 6 months.

Secondary outcome [1]

Loss of fracture position tested

Timepoint [1]

At 6 weeks

Secondary outcome [2]

Range of motion and grip strength tested

Timepoint [2]

At 6 weeks, 3 months and 6 months

Eligibility

Key inclusion criteria

Must be english speaking, of sound mind, to consent. fracture pattern must be complex, requiring at least 2 incisions and at least 2 forms of internal fixation (according to the staff orthoapedic surgeon).

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Non -english speaking, not of sound mind to consent, fracture not severe enough to require two forms of internal fixation.

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

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

Computer generated/Excel

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/06/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Northern Hospital, Melbourne

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Daniel Goldbloom

Address

Country

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Summary

Brief summary

To investigate whether aggressive physiotherapy achieves a better functional outcome than regular physiotherapy after operations for wrist fractures. The subjects are blinded. The Physiotherapist is not blinded. The surgeon is also blinded however this fact is not as much of a cornerstone to the study as the blinding status of the patients and the physiotherapist.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Daniel Goldbloom

Address

Northern Hospital
185 Cooper St
Epping 3076 VIC

Country

Australia

Phone

+61 3 84058000

Fax

+61 3 84058032

[email protected]

Contact person for scientific queries

Name

Dr Shane Blackmore

Address

Northern Hospital
185 Cooper St
Epping 3076 VIC

Country

Australia

Phone

+61 3 84058000

Fax

+61 3 84058032

[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

Source	Title	Year of Publication	DOI
Embase	Rehabilitation for distal radial fractures in adults.	2015	https://dx.doi.org/10.1002/14651858.CD003324.pub3

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

Trial Review

Documents added manually

Documents added automatically