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Trial registered on ANZCTR
Registration number
ACTRN12611000592943
Ethics application status
Not yet submitted
Date submitted
6/11/2010
Date registered
8/06/2011
Date last updated
8/06/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparing two methods of abductor repair in the Hardinge's approach for 100 consecutive patients undergoing total hip replacement and their effect on post-operative abductor insufficiency and repair failure.
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Scientific title
In patients undergoing total hip replacement using the Hardinge approach, is rasping of the anterior femoral cortex prior to abductor repair more effective than no rasping in terms of gait and evidence of repair?
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Secondary ID [1]
253037
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NA
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Universal Trial Number (UTN)
NA
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Trial acronym
NA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Failure of abductor repair in total hip replacement
258595
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Condition category
Condition code
Surgery
258737
258737
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Rasping of anterior femoral cortex prior to abductor repair to the anterior femoral cortex in closure of the Hardinge's approach for total hip replacement.
The Hardinge's approach involves exposing the hip joint for total hip replacement by detaching the anterior one third of the insertion of gluteus medius and minimus on the anterior proximal femur (the 'abductors'). After the hip replacement has been completed this tendinous attachment is repaired using sutures.
Rasping the site of boney attachment of the abductors would involve using a surgical instrument called a rasp to roughen the smooth cortical boney surface and expose underlying vascular boney architecture. This may take an additional one to two minutes of operating time when compared to repair of the abductors without rasping.
This is a one-off intervention at the time of closure of the Hardinge's exposure.
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Intervention code [1]
257564
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Treatment: Surgery
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Comparator / control treatment
No rasping of anterior femoral cortex prior to abductor repair to the anterior femoral cortex in closure of the Hardinge's approach for total hip replacement.
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Control group
Active
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Outcomes
Primary outcome [1]
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Incidence of abductor insufficiency gait as determined by clinician assessment
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Assessment method [1]
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Timepoint [1]
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6 weeks and six months post-operative
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Secondary outcome [1]
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Radiographic evidence of repair failure
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Assessment method [1]
266243
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Timepoint [1]
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6 weeks and six months post-operative
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Eligibility
Key inclusion criteria
Primary total hip replacement using the hardinge’s approach.
Pre-operative diagnosis of osteoarthritis or avascular necrosis.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pre-operative injury to the abductor mechanism.
Rhemuatoid arthritis.
Other connective tissue disease.
Total hip replacement for fracture neck of femur.
Current corticosteroid use.
Current disease modifying anti-rheumatoid drug use.
Neuromuscular disorder.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be asked at the time of consenting for routine primary total hip replacement if they are happy to be involved in the trial. If they are happy to consent after discussion and reading the patient information sheet they will be included in the study. At the time of abductor repair an OR nurse will open the envelope which will either allocate the patient to rasping or no rasping prior to abductor repair. The surgeon will be aware which group the patient was in as he will be performing the procedure. The patient will blinded to which technique was used. The technique used will not be included in the routine operation note so post-operative assessment of outcomes is somewhat blinded to which technique was used. (Note that no attempts will be made to prevent the operating surgeon from performing the post-operative assessments so blinding may not be complete in this respect). The patients ID sticker will be placed with the envelope randomisation card into a confidential collection box until the conclusion of the study period.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block-envelope randomisation technique
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
NA
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3022
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New Zealand
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State/province [1]
3022
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Hawkes Bay
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Funding & Sponsors
Funding source category [1]
258015
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Hospital
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Name [1]
258015
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Hawkes Bay hospital
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Address [1]
258015
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Omahu Road, Hastings
New Zealand
4120
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Country [1]
258015
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New Zealand
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Primary sponsor type
Hospital
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Name
Hawkes Bay hospital
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Address
Omahu Road, Hastings
New Zealand
4120
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Country
New Zealand
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Secondary sponsor category [1]
257208
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None
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Name [1]
257208
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Address [1]
257208
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Country [1]
257208
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
260031
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Ethics committee address [1]
260031
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Ethics committee country [1]
260031
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Date submitted for ethics approval [1]
260031
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19/11/2010
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Approval date [1]
260031
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Ethics approval number [1]
260031
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Summary
Brief summary
The aim of the study is to determine whether rasping (freshening using a surgical instrument) of the
surface of the femur (thigh bone) prior to re-attachment of tendons routinely detached to perform total
hip replacement improves their healing to the femur and their function as stabilisers during walking and
standing on one leg after hip replacement.
Pre-study statistical analysis performed by Mr Cameron Walker, Statistician from the University of
Auckland. Desired power 80%. Desired significance level 0.05. Effect size 0.5. 50 patients required in
each group for one-sided tests of significance. The analysis was performed using the “pwr” library in the R
package.
Block envelope Randomisation. First 100 consenting patients undergoing primary total hip replacement
by either Mr Dray or Mr Bentall using a Hardinge’s approach analysed. Randomised to either closure
of the abductor mechanism with or without rasping of the anterior femoral cortex prior to re-attachment.
Surgical clips secured on both ends of abductor repair for radiographic analysis of repair integrity. All
other aspects of surgery as per usual routine. Routine clinic follow-up post discharge at six weeks and six
months. Assessment of patient’s gait for abductor lurch, trendelenbergs test and radiographic review with
AP and lateral plain film X-rays of the hip. At the conclusion of the study Fisher’s exact test will be used to
compare rates of abductor lurch, positive trendelenberg’s test and radiographic evidence of repair failure
between the two groups.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31880
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Address
31880
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Country
31880
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Phone
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Fax
31880
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Email
31880
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Contact person for public queries
Name
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Dr Phillip Insull
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Address
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4 Belmont Terrace
Remuera
Auckland 1050
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Country
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New Zealand
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Phone
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+64210470846
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Fax
15127
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Email
15127
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[email protected]
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Contact person for scientific queries
Name
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Dr Phillip Insull
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Address
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4 Belmont Terrace
Remuera
Auckland 1050
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Country
6055
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New Zealand
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Phone
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+6421 0470846
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Fax
6055
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Email
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[email protected]
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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.
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