Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001714279
Ethics application status
Approved
Date submitted
2/10/2018
Date registered
17/10/2018
Date last updated
17/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is robotic arm assisted total hip replacement more bone preserving than conventional hip replacements and hip resurfacing?
Scientific title
Is robotic arm assisted total hip replacement more bone preserving than conventional hip replacements and hip resurfacing?
Secondary ID [1] 296226 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Replacement 309864 0
Hip Osteoarthritis 309865 0
Condition category
Condition code
Surgery 308659 308659 0 0
Surgical techniques
Musculoskeletal 308760 308760 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patient will undergo robotic total hip replacement as per normal practice. No additional intervention will take place. This is typically 60-90min procedure. The bone reamings will be collected and the dry weight will be measured after the patient has left the theatre.
Intervention code [1] 312554 0
Not applicable
Comparator / control treatment
Comparison group will be from Brennan et al (6) study

Brennan et al (6) compared dry bone weight of acetabular reaming of conventional THA vs Hip resurfacing. They found no statistically significant difference between both groups. Our study uses the same trident series acetabular component as Brennan et al. We plan to use their study as our comparison group.

6. Brennan SA, Harty JA, Gormley C, O'Rourke SK. Comparison of acetabular reamings during hip resurfacing versus uncemented total hip arthroplasty. J Orthop Surg (Hong Kong). 2009;17(1):42-6.
Control group
Historical

Outcomes
Primary outcome [1] 307616 0
Measurement of dry bone weight of acetabular bone reamings from robotic arm assisted total hip replacement.
Timepoint [1] 307616 0
Dry bone weight will be measured on the same day after the theatre list is complete and patients have left the operating theatre.
Secondary outcome [1] 352428 0
Complications during this series. This will include fractures and implant failures. Patients will be followed up for one year. X-rays will be taken day 1 post operatively, 6 weeks and 1 year.
Timepoint [1] 352428 0
1 year post operative

Eligibility
Key inclusion criteria
-Undergoing Robotic Arm Assisted Total Hip Replacement (THR)
-Primary THR for Osteoarthritis
-Uncemented Trident Cup
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Having Cemented THR
- Having conventional THR

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Brennan et al (Brennan SA, Harty JA, Gormley C, O'Rourke SK. Comparison of acetabular reamings during hip resurfacing versus uncemented total hip arthroplasty. J Orthop Surg (Hong Kong). 2009;17(1):42-6.) compared dry bone weight of acetabular reaming of conventional THA vs Hip resurfacing. They found no statistically significant difference between both groups. Our study uses the same trident series acetabular component as Brennan et al. We plan to use their study as our comparison group. We have an estimate for our baseline (conventional hip replacement): Mean = 12.76g, Standard deviation = 5.17g, N = 62. With a two-tailed test: Consider it possible that Robotic may be either higher or lower than Conventional. Assuming a medium effect size difference between Robotic and Conventional, then we would recruit N = 64 patients. We will be preparing the bone reamings in a similar way as Brennan et al (6) have done in their paper. Patient consent will be obtained from all patients. The study does not interfere with current surgery practice and flow.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
Date of last participant enrolment
Anticipated
1/02/2019
Actual
Date of last data collection
Anticipated
1/04/2020
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12054 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 24211 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 300825 0
Self funded/Unfunded
Name [1] 300825 0
Nil
Country [1] 300825 0
Primary sponsor type
Individual
Name
Arash Taheri
Address
Joondalup Orthopaedic Group
Suite 5, Ground Floor
Joondalup Private Hospital, 60 Shenton Ave
Joondalup WA 6027, Australia
Country
Australia
Secondary sponsor category [1] 300372 0
None
Name [1] 300372 0
nil
Address [1] 300372 0
nil
Country [1] 300372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301593 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 301593 0
Hollywood Private Hospital
Monash Ave
Nedlands
Perth
WA 6009
Ethics committee country [1] 301593 0
Australia
Date submitted for ethics approval [1] 301593 0
07/01/2018
Approval date [1] 301593 0
31/05/2018
Ethics approval number [1] 301593 0
HPH435

Summary
Brief summary
Primary total hip arthroplasty (THA) is an increasingly common procedure with 400331 procedures in Australia during 2016. This is 94.4% higher than the numbers undertaken in 2003. Literature suggests a revision rates ranging from 4% to 33% in this young population compared to 7%-15% for older patients. Loss of bone stock during primary THA may adversely affect subsequent revision THA. The purpose of this study was to compare preservation of acetabular bone stock between conventional THA and Hip resurfacing vs. robotic MAKO THA. We hypothesize that the robotic system would allow more precise reaming, leading to greater preservation of bone stock.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87498 0
Mr Arash Taheri
Address 87498 0
Joondalup Orthopaedic Group
Suite 5, Ground Floor
Joondalup Private Hospital, 60 Shenton Ave
Joondalup WA 6027, Australia
Country 87498 0
Australia
Phone 87498 0
+61 8 9300 1800
Fax 87498 0
Email 87498 0
[email protected]
Contact person for public queries
Name 87499 0
Dr Rajitha Gunaratne
Address 87499 0
Joondalup Orthopaedic Group
Suite 5, Ground Floor
Joondalup Private Hospital, 60 Shenton Ave
Joondalup WA 6027, Australia
Country 87499 0
Australia
Phone 87499 0
+61 0410990265
Fax 87499 0
Email 87499 0
[email protected]
Contact person for scientific queries
Name 87500 0
Dr Rajitha Gunaratne
Address 87500 0
Joondalup Orthopaedic Group
Suite 5, Ground Floor
Joondalup Private Hospital, 60 Shenton Ave
Joondalup WA 6027, Australia
Country 87500 0
Australia
Phone 87500 0
+61 0410990265
Fax 87500 0
Email 87500 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
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