Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000552280
Ethics application status
Approved
Date submitted
24/06/2009
Date registered
8/07/2009
Date last updated
4/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient satisfaction following total hip arthroplasty for osteoarthritis: a randomised controlled trial of the lateral and posterior approaches.
Scientific title
Patient satisfaction following total hip arthroplasty for osteoarthritis: a randomised controlled trial of the lateral and posterior approaches.
Secondary ID [1] 252367 0
1.2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total hip arthroplasty for osteoarthritis 237090 0
Condition category
Condition code
Surgery 237412 237412 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lateral approach to the hip

Division of fascia lata, subperiosteal dissection of anterior 1/3 of gluteus medius and origin of vastus lateralis, capsulotomy; total hip arthroplasty in the standard manner, repair of gluteus medius flap with 2 vicryl, duration of entire procedure approximately 90 minutes
Intervention code [1] 236807 0
Treatment: Surgery
Comparator / control treatment
Posterior approach to the hip
Division of fascia lata/gluteus maximus, elevation of short external rotators from lateral insertion, capsulotomy, total hip arthroplasty in the standard manner, short external rotator repair with non-absorbable suture, total duration of procedure ~90 minutes
Control group
Active

Outcomes
Primary outcome [1] 238215 0
Patient satisfaction as assessed by visual analogue pain score, Oxford hip score, Short Form-36 and Western Ontario and McMaster University Index
Timepoint [1] 238215 0
Assessment of the above at 6 weeks, 3 months, 6 months, 1 year post-operatively.
Secondary outcome [1] 244530 0
Prevalence of trochanteric bursitis as defined by at least 2 of the following 3: (i) lateral hip pain with a pain score of 3/10 or more (ii) lateral hip tenderness (iii) response to steroid injection as assessed by history and examination at a clinic appointment (at 6 months and 1 year, or more often if symptoms necessitate)
Timepoint [1] 244530 0
6 months, 1 year post-operatively

Eligibility
Key inclusion criteria
Osteoarthritis of the hip
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fracture neck of femur Malignancy affecting the hip Previous hip surgery Dementia hip anatomy incompatible with chosen implants on pre-operative templating

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)
Patients with a diagnosis of hip osteoarthitis requiring total hip arthroplasty and who do not have exclusion criteria will be offered participation in the trial, with the uncertainty regarding the best approach outlined. Consenting patients will be randomised to either the lateral or posterior approach on the day of operation. The patient will remain blinded; the surgical team will perform the lateral or posterior approach based on the contents of a sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Chronologically
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
302
Accrual to date
Final
Recruitment outside Australia
Country [1] 1853 0
New Zealand
State/province [1] 1853 0

Funding & Sponsors
Funding source category [1] 237203 0
Charities/Societies/Foundations
Name [1] 237203 0
N/A
Country [1] 237203 0
New Zealand
Primary sponsor type
Hospital
Name
Whangarei Hospital
Address
Maunu Rd
PO Box 9742
Whangarei 0110
Country
New Zealand
Secondary sponsor category [1] 4695 0
None
Name [1] 4695 0
Address [1] 4695 0
Country [1] 4695 0
Other collaborator category [1] 718 0
Individual
Name [1] 718 0
Mr. R. Coup
Address [1] 718 0
Whangarei Hospital
Maunu Rd
PO Box 9742
Whangarei 0110
Country [1] 718 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239298 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 239298 0
Ministry of Health
PO Box 1031
354 Victoria Street
Hamilton
New Zealand
Ethics committee country [1] 239298 0
New Zealand
Date submitted for ethics approval [1] 239298 0
31/07/2009
Approval date [1] 239298 0
14/04/2010
Ethics approval number [1] 239298 0
NTY/10/01/002

Summary
Brief summary
Patient satisfaction following total hip arthroplasty for osteoarthritis: a randomised controlled trial of the lateral and posterior approaches.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 29793 0
Address 29793 0
Country 29793 0
Phone 29793 0
Fax 29793 0
Email 29793 0
Contact person for public queries
Name 13040 0
Jonathan Manson
Address 13040 0
Orthopaedic Department
PO Box 742
Maunu Road
Whangarei
New Zealand
Country 13040 0
New Zealand
Phone 13040 0
0064 09 430 4100
Fax 13040 0
Email 13040 0
[email protected]
Contact person for scientific queries
Name 3968 0
Jonathan Manson
Address 3968 0
Orthopaedic Department
PO Box 742
Maunu Road
Whangarei
New Zealand
Country 3968 0
New Zealand
Phone 3968 0
0064 09 430 4100
Fax 3968 0
Email 3968 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
No additional documents have been identified.