Trial Review

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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.
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?
Secondary ID [1] 253037 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failure of abductor repair in total hip replacement 258595 0
Condition category
Condition code
Surgery 258737 258737 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257564 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 259602 0
Incidence of abductor insufficiency gait as determined by clinician assessment
Timepoint [1] 259602 0
6 weeks and six months post-operative
Secondary outcome [1] 266243 0
Radiographic evidence of repair failure
Timepoint [1] 266243 0
6 weeks and six months post-operative

Eligibility
Key inclusion criteria
Primary total hip replacement using the hardinge’s approach.

Pre-operative diagnosis of osteoarthritis or avascular necrosis.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block-envelope randomisation technique
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3022 0
New Zealand
State/province [1] 3022 0
Hawkes Bay

Funding & Sponsors
Funding source category [1] 258015 0
Hospital
Name [1] 258015 0
Hawkes Bay hospital
Country [1] 258015 0
New Zealand
Primary sponsor type
Hospital
Name
Hawkes Bay hospital
Address
Omahu Road, Hastings
New Zealand
4120
Country
New Zealand
Secondary sponsor category [1] 257208 0
None
Name [1] 257208 0
Address [1] 257208 0
Country [1] 257208 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260031 0
Ethics committee address [1] 260031 0
Ethics committee country [1] 260031 0
Date submitted for ethics approval [1] 260031 0
19/11/2010
Approval date [1] 260031 0
Ethics approval number [1] 260031 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31880 0
Address 31880 0
Country 31880 0
Phone 31880 0
Fax 31880 0
Email 31880 0
Contact person for public queries
Name 15127 0
Dr Phillip Insull
Address 15127 0
4 Belmont Terrace
Remuera
Auckland 1050
Country 15127 0
New Zealand
Phone 15127 0
+64210470846
Fax 15127 0
Email 15127 0
[email protected]
Contact person for scientific queries
Name 6055 0
Dr Phillip Insull
Address 6055 0
4 Belmont Terrace
Remuera
Auckland 1050
Country 6055 0
New Zealand
Phone 6055 0
+6421 0470846
Fax 6055 0
Email 6055 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.