ANZCTR - Registration

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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

21/09/2021

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]

None

Universal Trial Number (UTN)

Trial acronym

QUADRA-P

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hip Osteoathritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

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]

2-years (primary time-point), 5 and 10 years post-operatively

Secondary outcome [1]

Mean scores on patient reported outcome questionnaire EQ-5D-5L

Timepoint [1]