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Trial registered on ANZCTR


Registration number
ACTRN12620000441910
Ethics application status
Approved
Date submitted
11/03/2020
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
To assess the efficacy (survivorship) of the Quadra-P Hydroxyapatite coated femoral stem in patients undergoing a primary total hip replacement surgery.
Scientific title
Prospective, Multicentre Study to Assess Performance of the Quadra-P Femoral Stem in Primary Total Hip Replacement .
Secondary ID [1] 299843 0
None
Universal Trial Number (UTN)
Trial acronym
QUADRA-P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoathritis 315236 0
Condition category
Condition code
Musculoskeletal 313544 313544 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrollment in this study. Each participant will receive the new hydroxyapatite coated Quadra-P femoral stem together with either the Mpact or Versafit cementless acetabular component articular systems, as part of routine treatment for total hip replacement procedures. These devices will be implanted by qualified and experienced orthopaedic surgeons as per routine practice and all observational participant data will be collected into the AOANJRR registry as per standard protocols. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed by the AOANJRR during the pre-operative visit and again at 6 month, 1 year, 2 years, 5 years and 10 years time points post-procedure. Each patient will receive SMS/email reminders at each time to log into an online portal and complete each of the questionnaires, at the participant's home using an electronic device of their choice.
Intervention code [1] 316099 0
Not applicable
Comparator / control treatment
Based on National AOANJRR Data Revision notes, the survivorship of the Quadra-P stem at 2, 5 and 10 years post-surgery will be compared to the performance of all other commercially available femoral stems used in Australia for hip replacement procedures. The federally funded AOANJRR captures nearly all joint replacement procedures in Australia as part of Quality Assurance activities, thereby being the most suitable vehicle to allow for direct comparison of revision rates with all other stems. Comparison of the Quadra-P device will be made to the performance of all other stems during the time of which the trial is being conducted (i.e from date of first patient enrollment to date of last patient follow-up time point). Mean differences in patient reported outcomes measure (PROM) scores (EQ-5D-5L, oxford hip score, hip dysfunction, VAS and osteoarthritis score) will be obtained pre-surgery and again at 6 months, 1 year, 2 year , 5 years and 10 years post procedure to evaluate the extent of improvement/reduction in patient quality of life, level of pain, satisfaction and rate of complications, compared to scores obtained prior to surgery. There is no plan for these mean PROMS scores to be compared/analysed with other commercially available competitor devices.
Control group
Active

Outcomes
Primary outcome [1] 321996 0
To determine QUADRA-P Stem survivorship (efficacy) at 2, 5 and 10 years post-operatively compared to all other cementless femoral stems. Survivorship will be assessed by determining the time to first revision surgery required following implantation of the Quadra-P stem device. If time to first revision rates are comparable to other commercially available stems, this is indicative that Quadra-P is efficacious. These estimates will be calculated using Kaplan-Meier estimates of survivorship,
Timepoint [1] 321996 0
2-years (primary time-point), 5 and 10 years post-operatively
Secondary outcome [1] 376945 0
Mean scores on patient reported outcome questionnaire EQ-5D-5L

Timepoint [1] 376945 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [2] 376946 0
Mean scores on patient reported outcome questionnaire Oxford Hip Score (OHS)
Timepoint [2] 376946 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [3] 381297 0
Mean scores on patient reported outcome questionnaire Hip Dysfunction and Osteoarthritis Score (HOOS)
Timepoint [3] 381297 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [4] 381298 0
Mean scores on patient reported outcome questionnaire Visual Analogue Score (VAS) for Pain
Timepoint [4] 381298 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [5] 381299 0
Number of complications following surgery, including
- Infection rates, aseptic loosening and other causes. These parameters will be documented Registry Data and also from responses to patient questions and phone follow-up (if required)
- Death. This will be determined by linkage to the National Death Index (NDI)
-Medications, hospital admissions and other surgery. These parameters will be determined through linkage with Government data.
Timepoint [5] 381299 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery

Eligibility
Key inclusion criteria
- Patients undergoing a primary total conventional hip replacement
- Patients assessed by the investigators as being suitable for placement of a straight, cementless stem.
- Adult male and female less than 75 years of age at time of registration
- Ability to give informed consent
- Patients who are informed of the conditions of the study are are willing to participate for the length of the prescribed follow-up
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with Rhematoid arthritis
- Patients with a history of active infection
- Any case not described in the inclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Kaplan-Meier estimates of survivorship will be used to describe the time to first revision (or time to death) of the Quadra-P prosthesis (used in combination with the Versafit and Mpact acetabular components). These estimates are defined as the cumulative percent revision (CPR) at specified years which is the complement (in probability) of the Kaplan-Meier estimates, multiplied by 100. Hazard ratios will be determined using Cox proportional hazards models to compare the rate of revision between the Quadra-P stem vs all other cementless stems. If the hazard ratio is not proportional, them a time varying model will be used.

The change in patient reported outcome measures between pre- and post procedure will be analysed using generalised linear mixed models. A normal distribution will be assumed for continuous outcomes (such as Oxford Hip Score). A cumulative logit model will be considered for outcomes where there is a Likert scale (such as EQ-5D-5L). All analyses will be adjusted for age, gender and Body Mass Index.

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 304301 0
Commercial sector/Industry
Name [1] 304301 0
Medacta Australia Pty Ltd
Address [1] 304301 0
Unit A1, 16 Mars Road, Lane Cove, NSW 2066
Country [1] 304301 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia Pty Ltd
Address
Unit A1, 16 Mars Road, Lane Cove, NSW 2066
Country
Australia
Secondary sponsor category [1] 305575 0
None
Name [1] 305575 0
Address [1] 305575 0
Country [1] 305575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304755 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 304755 0
GPO Box 2471
Adelaide, SA, 5001
Ethics committee country [1] 304755 0
Australia
Date submitted for ethics approval [1] 304755 0
04/12/2019
Approval date [1] 304755 0
11/12/2019
Ethics approval number [1] 304755 0
Ethics committee name [2] 305612 0
Sydney South West Local Health District
Ethics committee address [2] 305612 0
Research Directorate
Locked Bag 7103
Liverpool BC NSW 1871
Ethics committee country [2] 305612 0
Australia
Date submitted for ethics approval [2] 305612 0
31/01/2020
Approval date [2] 305612 0
10/03/2020
Ethics approval number [2] 305612 0

Summary
Brief summary
Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status. Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening, stem fractures and reduced functional movement, which lead to poorer patient outcomes. Recently, a new range of hip replacement devices have been engineered to address some of the shortcomings of existing stems. In particular, the Quadra-P stem has specifically been designed as a straight, triple tapered stem with a rectangular cross-section and manufactured with Ti-6Al-7Nb alloy material to increase osseointegration and reduce wear. The newly designed Quadra-P stem device was recently introduced into the Australian market, however, its clinical performance is yet to be evaluated. Thus, the purpose of this study is to investigate the Quadra-P stem efficacy (survival) at 2, 5 and 10 years post-surgery and ensure that it performs just as well as other commercially available stems. The hypothesis for this investigation is that the 2, 5 and 10 year percent revision rate (need to re-implant) is not inferior (comparable) to the average performance of all other cementless femoral stems currently in use in the Australian Market.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98098 0
A/Prof Phong Tran
Address 98098 0
Head of Orthopaedics
Western Health
Ground Floor, 166 Gipps Street
East Melbourne VIC 3002
Country 98098 0
Australia
Phone 98098 0
+61 3 9928 6161
Fax 98098 0
Email 98098 0
phong.tran@wh.org.au
Contact person for public queries
Name 98099 0
A/Prof Phong Tran
Address 98099 0
Head of Orthopaedics
Western Health
Ground Floor, 166 Gipps Street
East Melbourne VIC 3002
Country 98099 0
Australia
Phone 98099 0
+61 3 9928 6161
Fax 98099 0
Email 98099 0
phong.tran@wh.org.au
Contact person for scientific queries
Name 98100 0
Dr Victoria Dokic
Address 98100 0
Medacta International
Unit A1, 16 Mars Road
Lane Cove, NSW 2066
Country 98100 0
Australia
Phone 98100 0
+61 1300 631 790
Fax 98100 0
Email 98100 0
victoria.dokic@medacta.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain patient confidentiality and comply with international privacy laws, individual participant data will not be available for this trial.
What supporting documents are/will be available?
No other documents available
Summary results
No Results