Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000551099
Ethics application status
Approved
Date submitted
15/06/2010
Date registered
8/07/2010
Date last updated
13/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimally invasive hip replacement for osteoarthritis of the hip - a randomised trial
Scientific title
A comparative study of minimally invasive total hip replacement for osteoarthritis, with emphasis on complications and clinical scores
Secondary ID [1] 252026 0
Nil
Universal Trial Number (UTN)
U1111-1115-5024
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the hip 257571 0
Condition category
Condition code
Musculoskeletal 257738 257738 0 0
Osteoarthritis
Surgery 257889 257889 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-incision mini-posterior approach to the hip. This technique involves a smaller incision (around 10cm) and sparing of some short external rotators (namely Piriformis) than a standard approach. Each approach takes the same time (around 60-90 minutes)
Intervention code [1] 256751 0
Treatment: Surgery
Comparator / control treatment
Standard posterior approach to the hip. This approach involves a generous incision (around 20cm), and detachment of all short external rotator muscles. Each approach takes the same time (around 60-90 minutes)
Control group
Active

Outcomes
Primary outcome [1] 258619 0
Complication rate from surgery, including fractures, infection and dislocation. These will be assessed clinically and by xray
Timepoint [1] 258619 0
2 weeks, 6 weeks, 3 months, 1 year and 2 years post-operation
Secondary outcome [1] 264555 0
Clinical scores (function): Oxford Hip Score, 6-minute walk test
Timepoint [1] 264555 0
3 months, 1 year and 2 years post-operation
Secondary outcome [2] 264765 0
Satisfaction: Visual analogue scale
Timepoint [2] 264765 0
3 months, 1 year and 2 years post-operation
Secondary outcome [3] 264978 0
The impact on the muscle of cutting the tendon (in the standard group) using the preserved tendon (in the less invasive group) as a control. This outcome is assessed using magnetic resonance imaging (MRI) of the Piriformis and Obturator Internus in a subgroup of 20 patients.
Timepoint [3] 264978 0
Preoperative, and 3 months and 2 years postoperative.

Eligibility
Key inclusion criteria
Primary osteoarthritis (OA) of the hip
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery to the hip
Trauma to the hip
Dysplasia

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)
Enrolled through outpatient clinic. Allocation concealment using central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2005
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
3/11/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257136 0
Self funded/Unfunded
Name [1] 257136 0
Country [1] 257136 0
Primary sponsor type
Individual
Name
Riaz Khan
Address
Suite 1, Hollywood Medical Centre, 85 Monash Ave, Nedlands, WA 6009, Australia
Country
Australia
Secondary sponsor category [1] 256396 0
None
Name [1] 256396 0
Address [1] 256396 0
Country [1] 256396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259174 0
Sir Charles Gairdner Group Human research Ethics Committee
Ethics committee address [1] 259174 0
Level 2, A Block, Hospital Ave, Nedlands, WA 6009
Ethics committee country [1] 259174 0
Australia
Date submitted for ethics approval [1] 259174 0
05/02/2004
Approval date [1] 259174 0
15/10/2004
Ethics approval number [1] 259174 0
2008 - 158

Summary
Brief summary
There has been a recent drive to perform hip replacements through smaller incisions. The question is, does this increase the risk of complications? The primary purpose was to assess whether a hip replaced through a smaller incision produced as good a result as when done through a standard incision. Our hypothesis was that it did, and was possibly more beneficial since fewer tissues were divided.
Trial website
Trial related presentations / publications
A comparison of a less invasive Piriformis-sparing approach versus the standard posterior approach to the hip.
Khan RJK, Maor D, Hofmann M and Haebich S.
JBJS Br 2012; 94B (1): 43-50
Public notes

Contacts
Principal investigator
Name 31292 0
Prof Riaz Khan
Address 31292 0
The Joint Studio, 85 Monash Ave, Nedlands, WA 6009
Country 31292 0
Australia
Phone 31292 0
+61 8 93863933
Fax 31292 0
Email 31292 0
[email protected]
Contact person for public queries
Name 14539 0
Prof Riaz Khan
Address 14539 0
Suite 1, Hollywood Medical Centre, 85 Monash Ave, Nedlands, 6009, WA
Country 14539 0
Australia
Phone 14539 0
+61 8 93863933
Fax 14539 0
+61 8 93863015
Email 14539 0
[email protected]
Contact person for scientific queries
Name 5467 0
Prof Riaz Khan
Address 5467 0
Suite 1, Hollywood Medical Centre, 85 Monash Ave, Nedlands, 6009, WA
Country 5467 0
Australia
Phone 5467 0
+61 8 93863933
Fax 5467 0
+61 8 93863015
Email 5467 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.