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Trial registered on ANZCTR


Registration number
ACTRN12619000003178
Ethics application status
Approved
Date submitted
17/12/2018
Date registered
8/01/2019
Date last updated
17/05/2019
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
8/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bone remodelling and density of the pelvis following implantation of the delta TT acetabular cup in patients undergoing primary total hip replacement for hip arthritis
Scientific title
Bone remodelling and density of the pelvis following implantation of the delta TT acetabular cup in patients undergoing primary total hip replacement for hip arthritis
Secondary ID [1] 296888 0
Protocol number (Medical Device Research Australia): P0125-001. Rev D
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip replacement 310825 0
Condition category
Condition code
Musculoskeletal 309497 309497 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing primary total hip replacement for osteoarthritis of the hip. Intervention was by one of two experienced consultant orthopaedics surgeons (hip specialists). DEXA scans were used to measure the bone mineral density behind the cup at various intervals post op.
Intervention code [1] 313164 0
Treatment: Surgery
Intervention code [2] 313184 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308459 0
The change in bone mineral density due to bone remodelling behind the acetabular component measured with DEXA scans to the hip & pelvis at various intervals over two years.
Timepoint [1] 308459 0
DEXA scans were performed at six weeks, six months, one year and two years after surgery
Secondary outcome [1] 355000 0
Clinical review (assessment of complications and revision surgery)
Timepoint [1] 355000 0
At six weeks, six months, one year and two years after surgery
Secondary outcome [2] 365183 0
Hip pain at rest assessed using a 100mm Visual Analogue Scale (VAS)
Timepoint [2] 365183 0
At six weeks, six months, one year and two years after surgery
Secondary outcome [3] 365184 0
Hip function and pain assessed using Oxford Hip Score (composite outcome)
Timepoint [3] 365184 0
At six weeks, six months, one year and two years after surgery
Secondary outcome [4] 365322 0
Hip pain at mobilisation assessed using a 100mm Visual Analogue Scale (VAS)
Timepoint [4] 365322 0
At six weeks, six months, one year and two years after surgery

Eligibility
Key inclusion criteria
Patients with rheumatoid or osteoarthritis of the hip who are candidates for a primary total hip replacement.

Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with active infection, acute hip fracture, Patients who have had previous hip surgery. Patients with presence of malignancy in the hip joint area. Patient having surgery with other types of components. Patients who are mentally incompetent or unlikely to be compliant with the prescribed follow up evaluation schedule. Patients greater 125kg. Patients with a neuromuscular or concurrent illness which may affect their outcome.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21130 0
New Zealand
State/province [1] 21130 0
Auckland

Funding & Sponsors
Funding source category [1] 301460 0
Commercial sector/Industry
Name [1] 301460 0
LIMA Orthopedics Australia
Address [1] 301460 0
20 Crummer Road
Auckland 1021
Country [1] 301460 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
LIMA Orthopeadics
Address
20 Crummer Road
Auckland 1021
Country
New Zealand
Secondary sponsor category [1] 301151 0
Hospital
Name [1] 301151 0
North Shore Hospital
Address [1] 301151 0
Shakespeare Road
Takapuna
AUCKLAND 0622
Country [1] 301151 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302194 0
Southern Health and Disabilities Ethics committee
Ethics committee address [1] 302194 0
Health and Disability Ethics Committees
C/-Medsafe, Level 6, Deloitte house
10 Brandon Street
PO Box 5013
Wellington
Ethics committee country [1] 302194 0
New Zealand
Date submitted for ethics approval [1] 302194 0
Approval date [1] 302194 0
02/12/2013
Ethics approval number [1] 302194 0
13/STH90

Summary
Brief summary
Total hip engineering and surgery are in a state of constant research development and improvement. The literature presents a plethora of alternative bearing materials and combinations as well as geometries, dimensions and fixation methods. Despite continued popularity of hip arthroplasty as effective treatment for patients experiencing end stage osteoarthritis, the acetabular component of the arthroplasty remains a limiting factor in the longevity of the arthroplasty.

Cup wear and aseptic loosening are the main causes of failure. These have been associated with micro-motion in modular components and non fixation of the bone-implant interface.

The Delta-TT cup uses a combination of the modularity of the Delta acetabular system with the porous structure of the Trabecular Tritanium. The Delta-TT cup is made of Ti6AI4V tritanium alloy which is bio-compatible and effective in biological fixation and has been used in the orthopedic sector for over 30 years.

Bone density is a good indicator of the bone's response to implantation and its potential longer term success. Bone remodeling behavior following arthoplasty may be investigated radiographically. DEXA measurements are the gold-standard for measuring bone mineral density (BMD) and have been used extensively in clinical practice. Although DEXA is an established assessment technique in proximal femurs, there are relatively few reports in BMD in the acetabular region following total hip arthroplasty.

In cases where clinical data is not yet available, it is desirable to predict the mid-term outcomes of an arthroplasty. Bone remodeling algorithms may be used with computer modelling techniques to detect these bony remodeling changes. Using this methodology it is possible to analyse more than one design in a parametric and comparable manner, at a minimal cost to the patient, designer and manufacturer. To our knowledge, however only one study has predicated bone remodeling behavior in the acetabulum following total hip arthroplasty. This method has been validated using data in the literature.

It is proposed in this study to carry out a clinical DEXA study and a bone remodeling analysis of the Delta-TT cup.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89434 0
Mr William Farrington
Address 89434 0
Waitemata District Health Board
North Shore Hospital
Shakespeare Road
Takapuna
AUCKLAND 0622
Country 89434 0
New Zealand
Phone 89434 0
+64 486 8900
Fax 89434 0
Email 89434 0
william.farrington@waitematadhb.govt.nz
Contact person for public queries
Name 89435 0
Mr William Farrington
Address 89435 0
Waitemata District Health Board
North Shore Hospital
Shakespeare Road
Takapuna
AUCKLAND 0622
Country 89435 0
New Zealand
Phone 89435 0
+64 486 8900
Fax 89435 0
Email 89435 0
william.farrington@waitematadhb.govt.nz
Contact person for scientific queries
Name 89436 0
Mr William Farrington
Address 89436 0
Waitemata District Health Board
North Shore Hospital
Shakespeare Road
Takapuna
AUCKLAND 0622
Country 89436 0
New Zealand
Phone 89436 0
+64 486 8900
Fax 89436 0
Email 89436 0
william.farrington@waitematadhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case by case basis at the discretion of the principal investigator
Available for what types of analyses?
For statistical analysis, publication and presentation
How or where can data be obtained?
Access subject to approval by PI
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary