Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000555853p
Ethics application status
Submitted, not yet approved
Date submitted
9/03/2021
Date registered
12/05/2021
Date last updated
12/05/2021
Date data sharing statement initially provided
12/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Radiological Evaluation of the Performance of the Cementless Quadra-P Stem used for Total Hip Arthroplasty.
Scientific title
Clinical and Radiographic Performance of the Cementless Quadra-P Stem: A Retrospective and Prospective Observational Cohort Study of Adults Requiring Total Hip Arthroplasty
Secondary ID [1] 303608 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study related and being run in conjunction to registration record ACTRN12620000441910.

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 320978 0
Condition category
Condition code
Musculoskeletal 318787 318787 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.

The newly designed Quadra-P stem device was recently introduced into the Australian market (TGA approval granted 27th February 2019), however, its short and long-term clinical and radiological performance is yet to be evaluated. The AOANJRR is currently undertaking a registry-nested clinical trial (Medacta Quadra-P Femoral Stem, ACTRN12620000441910.) investigating the survivorship and patient reported outcomes (PROMs) following implantation of the Quadra-P stem in patients undergoing total hip replacement. However, it is currently unknown whether the new Quadra-P device reduces or has the same level of risk of loosening, fractures and implant displacement, compared to other commercially available stems. The purpose of this current investigation will be to determine the radiological performance of the Quadra-P stem in providing implant stability to ensure it performs as well as or better than other commercially available stems. Patients will be retrospectively recruited and all those who have already consented to be a part of the Quadra-P stem registry-nested PROMs study (ACTRN12620000441910) will be invited to participate in the radiological study.

Several radiological measurements will be taken in order to evaluate the performance and stability of the Quadra-P stem. Patients will be required to have an x-ray of their replaced hip (of approximately 30 minutes duration) at 4 different time points (6-weeks, 1-year, 2-years and 5-years post-op) The specific measurements that will be collected include presence of radiolucencies (femur and acetabulum), leg length discrepancy, global offset reconstructions, stem alignment, stem subsidence and presence of femoral fracture. All patients whp
Intervention code [1] 319933 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326780 0
Presence of Radiolucencies as assessed by x-ray
Timepoint [1] 326780 0
2-years post-surgery
Secondary outcome [1] 392661 0
Presence of Leg length discrepancy as assessed by x-ray
Timepoint [1] 392661 0
6-weeks, 1-year, 2-years and 5-years post-surgery
Secondary outcome [2] 392662 0
Presence of Global Offset Reconstruction as assessed by x-ray
Timepoint [2] 392662 0
6-weeks, 1-year, 2-years and 5-years post-surgery
Secondary outcome [3] 392663 0
Degree of stem alignment as assessed by x-ray
Timepoint [3] 392663 0
6-weeks, 1-year, 2-years and 5-years post-surgery
Secondary outcome [4] 392664 0
Degree of stem subsidence as assessed by x-ray
Timepoint [4] 392664 0
6-weeks, 1-year, 2-years and 5-years post-surgery
Secondary outcome [5] 392665 0
Presence of Radiolucencies as assessed by x-ray
Timepoint [5] 392665 0
6-weeks, 1 year and 5 years post-surgery
Secondary outcome [6] 392666 0
Presence of femoral fracture as assessed by x-ray
Timepoint [6] 392666 0
6-weeks, 1-year, 2-years and 5-years post-surgery

Eligibility
Key inclusion criteria
• Patients agreed to participate in the Quadra-P Femoral Stem Study (ACTRN12620000441910. University of South Australia HREC project ID: 202658)
• Adults aged between 18 and 75 years at the time of registration.
• Patients able to give informed consent.
• Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with Rheumatoid arthritis.
• Patients with a history of active infection.
• Any case not described in the inclusion criteria.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Stem radiological performance will be assessed via the specified parameters at 1-year, 2-years at 5-years post-surgery and compared to baseline x-ray obtained at 6-weeks. Any presence of radiolucencies, leg length discrepancies, changes in stem alignment, femoral fracture, global offset reconstruction or stem subsidence will be documented.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/06/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 308028 0
Commercial sector/Industry
Name [1] 308028 0
Medacta Australia Pty Ltd
Country [1] 308028 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] 308799 0
None
Name [1] 308799 0
Address [1] 308799 0
Country [1] 308799 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308018 0
St Vincents Hospital Melbourne HREC
Ethics committee address [1] 308018 0
Research Governance Unit
Level 5, Building E
27 Fitzroy Parade
Fitzroy VIC 3065
Ethics committee country [1] 308018 0
Australia
Date submitted for ethics approval [1] 308018 0
02/03/2021
Approval date [1] 308018 0
Ethics approval number [1] 308018 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 radiological performance is yet to be evaluated. It is currently unknown whether the new Quadra-P device reduces or has the same level of risk of loosening, fractures and implant displacement, compared to other commercially available stems. The purpose of this current investigation will be to evaluate the radiological performance of the Quadra-P stem in providing implant stability in patients undergoing THA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109250 0
A/Prof Phong Tran
Address 109250 0
Associate Professor Phong Tran Private Consulting Rooms
Specialist Orthopaedic Surgery Clinic
Ground Floor, St Francis Building
166 Gipps Street
East Melbourne, Victoria, 3002
Country 109250 0
Australia
Phone 109250 0
+61399286161
Fax 109250 0
Email 109250 0
[email protected]
Contact person for public queries
Name 109251 0
Phong Tran
Address 109251 0
Associate Professor Phong Tran Private Consulting Rooms
Specialist Orthopaedic Surgery Clinic
Ground Floor, St Francis Building
166 Gipps Street
East Melbourne, Victoria, 3002
Country 109251 0
Australia
Phone 109251 0
+61399286161
Fax 109251 0
Email 109251 0
[email protected]
Contact person for scientific queries
Name 109252 0
Phong Tran
Address 109252 0
Associate Professor Phong Tran Private Consulting Rooms
Specialist Orthopaedic Surgery Clinic
Ground Floor, St Francis Building
166 Gipps Street
East Melbourne, Victoria, 3002
Country 109252 0
Australia
Phone 109252 0
+61399286161
Fax 109252 0
Email 109252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.