Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000367246
Ethics application status
Approved
Date submitted
10/02/2009
Date registered
27/05/2009
Date last updated
15/11/2018
Date data sharing statement initially provided
15/11/2018
Date results information initially provided
15/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Clinical trial of Pain and mobility folllowing Cemented vs Uncemented Hemiarthroplasty in elderly patients with hip fracture.
Scientific title
A Randomised Clinical trial of Pain and mobility folllowing Cemented vs Uncemented Hemiarthroplasty in elderly patients with displaced subcapital neck of femur fracture.
Secondary ID [1] 262204 0
hemiarthoplasty trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Displaced subcapital neck of femur fracture 4301 0
Condition category
Condition code
Surgery 4533 4533 0 0
Other surgery
Musculoskeletal 237199 237199 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cemented hemiarthroplasty. This operation is to be performed through a Rorabeck Modification of the Hardinge Approach. The conjoined tendon of Vastus Lateralis and Gluteus removed in continuity with the capsule from anterior of Gt. Trochanter. An anterior superior capsulotomy is then performed with an incision directly along the line of the Femoral neck. Cementing is to be performed with second generation technique including Simplex cement with antibiotic mixed in a bowl and poured into insertion gun. Lavage and cement plug should be inserted prior. The cement shopuld be inserted retrograde and major pressurization avoided. Anteversion should be camparable to native anteversion and offset measured from digital xray prior to surgery. The stem insertion amount should also be measured prior to procedure during the templating process.

This intervention takes approximately one hour of surgical time
Intervention code [1] 4030 0
Treatment: Devices
Intervention code [2] 236634 0
Treatment: Surgery
Comparator / control treatment
Uncemented hemiarthroplasty. This operation is to be performed through a Rorabeck Modification of the Hardinge Approach. The conjoined tendon of Vastus Lateralis and Gluteus removed in continuity with the capsule from anterior of Gt. Trochanter. An anterior superior capsulotomy is then performed with an incision directly along the line of the Femoral neck.Anteversion should be camparable to native anteversion and offset measured from digital xray prior to surgery. The stem insertion amount should also be measured prior to procedure during the templating process.
This intervention take approximately 50 minutes of surgical time.
Control group
Active

Outcomes
Primary outcome [1] 5411 0
Pain via visual analogue score
Timepoint [1] 5411 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years
Secondary outcome [1] 9097 0
Oxford Hip Score (internationally validated scoring system for hip function)
Timepoint [1] 9097 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years
Secondary outcome [2] 9098 0
Mortality, (in hospital or post discharge)
Timepoint [2] 9098 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years
Secondary outcome [3] 9099 0
Gait and mobility, using timed up and go test.
Timepoint [3] 9099 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years
Secondary outcome [4] 9100 0
Ability to return to prefracture residence as determined by current residence at each followup period
Timepoint [4] 9100 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years
Secondary outcome [5] 9101 0
Short Form-12 assessment of quality of life
Timepoint [5] 9101 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years
Secondary outcome [6] 9102 0
Physical examination during clinic visits with monitering by trained orthopaedic nurse blinded to initial procedure.
Timepoint [6] 9102 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years
Secondary outcome [7] 9103 0
Complications of surgery prospectively and retrospectively identified by helath care professionals.
Timepoint [7] 9103 0
Post- operatively at 6 weeks, 6 months, 1 year, and 2 years

Eligibility
Key inclusion criteria
All patients presenting to Auckland Hospital requiring hemiarthroplasty will be offered entry into the trial.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe systemic disease recognized by the admitting team causing the patient to be unsuitable for the use of cement during the procedure.

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 patients presenting to Auckland Hospital requiring hemiarthroplasty will be offered entry into the trial.
After appropriate consent the patients will be randomised to either a cemented or a uncemented Hemiarthroplasty by a numbered opaque envelope opened in the operating room. Each patient then discussed with trial supervisor by telephone to ensure sequence followed.

Followup will be at 6 weeks, 6 months, 1 year and 2 years following surgery. At each follow up the patient will be seen and assessed by an experienced orthopaedic research nurse blinded to the initial procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Previous randomisation by random number generator provided by www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2006
Actual
15/05/2006
Date of last participant enrolment
Anticipated
Actual
27/11/2008
Date of last data collection
Anticipated
Actual
27/11/2010
Sample size
Target
160
Accrual to date
Final
160
Recruitment outside Australia
Country [1] 1564 0
New Zealand
State/province [1] 1564 0

Funding & Sponsors
Funding source category [1] 4477 0
Government body
Name [1] 4477 0
Accident Compensation Corporation
Country [1] 4477 0
New Zealand
Primary sponsor type
Government body
Name
ACC
Address
81-83 Molesworth St
Wellington 6140
PO Box 242
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 4036 0
None
Name [1] 4036 0
Address [1] 4036 0
Country [1] 4036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6538 0
Northern Y Regional Ethics Committee.
Ethics committee address [1] 6538 0
C/- Ministry of Health 3rd floor, BNZ Building 354 Victoria St (PO Box 1031) Hamilton 3240
Ethics committee country [1] 6538 0
New Zealand
Date submitted for ethics approval [1] 6538 0
15/03/2006
Approval date [1] 6538 0
20/03/2006
Ethics approval number [1] 6538 0
NTY/05/12/101

Summary
Brief summary
Hip fracture is a very common presentation to hospital. The patient group is elderly and is associated with a long hospital stay often requiring extensive rehabilitation. Many of these patients suffer significant pain and disability following fracture and as a consequence of this are unable to return to their previous residence incurring significant cost increase associated with a higher level of care.
This study has the potential to improve the outcome of these patients, reduce costly time in hospital and the requirement for further care following discharge related to reduced mobility.
If either cemented or uncemented hemiarthroplasty is shown to improve pain control and increase mobility this will significantly improve outcome for these patients.
Trial website
n/a
Trial related presentations / publications
Taylor F, Wright M, Zhu M. Hemiarthroplasty of the Hip with and without Cement: A Randomized Clinical Trial.
Journal Bone Joint Surgery (American). 2012 Apr 4;999(2):577-83
Public notes

Contacts
Principal investigator
Name 29267 0
Address 29267 0
Country 29267 0
Phone 29267 0
Fax 29267 0
Email 29267 0
Contact person for public queries
Name 12514 0
Fraser Taylor
Address 12514 0
29 Home st
Grey Lynn
Auckland 1021
Country 12514 0
New Zealand
Phone 12514 0
+64 21435837
Fax 12514 0
Email 12514 0
[email protected]
Contact person for scientific queries
Name 3442 0
Fraser Taylor
Address 3442 0
29 Home st
Grey Lynn
Auckland 1021
Country 3442 0
New Zealand
Phone 3442 0
+64 21435837
Fax 3442 0
Email 3442 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.