Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000216314
Ethics application status
Not yet submitted
Date submitted
13/04/2008
Date registered
21/04/2008
Date last updated
21/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
An Outcome Study to compare the Direct Anterior (Heuter) and Direct Lateral (Hardinge) approaches in total hip joint replacement
Scientific title
An Outcome Study to compare the Direct Anterior (Heuter) and Direct Lateral (Hardinge) approaches in total hip joint replacement. The outcome measures will include improved rehabilitation, length of hospital stay, complications and accuracy of component placement.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Replacement for arthritis of the hip. 3044 0
Condition category
Condition code
Surgery 3212 3212 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be having Total Hip Joint Replacement surgery. Half will have this surgery performed through an anterior muscle sparing approach .
The operation takes approximately one hour.
The study is anticipated to take 6 months - 12 months for enrolment and 12 months additional follow up; atotal of 12-18 months.
Intervention code [1] 2793 0
Treatment: Surgery
Comparator / control treatment
The other half of the participants will receive surgery performed through the lateral approach.In all other respects the treatment is identical.
Control group
Active

Outcomes
Primary outcome [1] 4085 0
Return to full activity.
Timepoint [1] 4085 0
Preoperative assessment, operative assessment and follow up at six weeks, three, six and twelve months.
Primary outcome [2] 4086 0
Accuracy of implant placement.
Timepoint [2] 4086 0
Postoperative xray.
Secondary outcome [1] 6878 0
Length of hospital stay.
Timepoint [1] 6878 0
Time of discharge from hospital.

Eligibility
Key inclusion criteria
Patients undergoing Total Hip Replacement.
Minimum age
30 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Obesity.
Marked joint stiffness.

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)
All subjects are enrolled sequentially. The order of treatment has been allocated by random number generation.
Allocation is performed by contacting a Theatre Nurse who holds the Allocation Schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Numbers were drawn in lottery style.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patient outcomes are measured by patients completing a validated scoring form.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3306 0
Self funded/Unfunded
Name [1] 3306 0
John Marshall O'Donnell
Country [1] 3306 0
Australia
Primary sponsor type
Individual
Name
John Marshall O'Donnell
Address
21 Erin St
Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 2948 0
None
Name [1] 2948 0
Address [1] 2948 0
Country [1] 2948 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5279 0
St Vincent's Mercy Private Hospital
Ethics committee address [1] 5279 0
Grey St
East Melbourne VIC 3002
Ethics committee country [1] 5279 0
Australia
Date submitted for ethics approval [1] 5279 0
17/04/2008
Approval date [1] 5279 0
Ethics approval number [1] 5279 0

Summary
Brief summary
40 patients who are to undergo total hip replacement (THR) will be randomly allocated to either Anterior or Lateral Groups. Otherwise identical THR operations will be performed.
Xrays will be assessed for component positioning.
Patients will fill out a self assessment form at Preop, and Postop 6 weeks, 3, 6, and 12 months
(Harris Hip Score )
Objective data collection will include blood loss, length of Hospital stay, and time on crutches.
Trial website
Nil
Trial related presentations / publications
AOA Hobart Oct 08
Public notes

Contacts
Principal investigator
Name 28524 0
Address 28524 0
Country 28524 0
Phone 28524 0
Fax 28524 0
Email 28524 0
Contact person for public queries
Name 11681 0
John Marshall O'Donnell
Address 11681 0
21 Erin St
Richmond VIC 3121
Country 11681 0
Australia
Phone 11681 0
+61 3 94216133
Fax 11681 0
+61 3 94216144
Email 11681 0
john@johnodonnell.com.au
Contact person for scientific queries
Name 2609 0
John Marshall O'Donnell
Address 2609 0
21 Erin St
Richmond VIC 3121
Country 2609 0
Australia
Phone 2609 0
+61 3 94216133
Fax 2609 0
+61 3 94216144
Email 2609 0
john@johnodonnell.com.au

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
No additional documents have been identified.