Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000550303
Ethics application status
Approved
Date submitted
30/03/2016
Date registered
19/04/2017
Date last updated
7/10/2021
Date data sharing statement initially provided
7/10/2021
Date results information initially provided
7/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, observational, cohort study of the MASTER-SL Femoral stem in patients with degenerative disease of the hip
Scientific title
In patients with Osteoarthritis of the hip undergoing a Total Hip Replacement, how does the MASTER-SL femoral stem perform under standard conditions with regards to clinical outcomes.
Secondary ID [1] 283934 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 290953 0
Condition category
Condition code
Musculoskeletal 291299 291299 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
50 patients to undergo Total Hip Replacement, the prosthesis used for the trial is MASTER-SL femoral stem. Patients will be followed up for functional and radiological assessments and side effects for a minimum of two years post surgery.
Intervention code [1] 288630 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291297 0
Clinical Outcome Scores: harris Hip Score,
Timepoint [1] 291297 0
Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op
Primary outcome [2] 298090 0
Outcome score: Oxford Hip
Timepoint [2] 298090 0
Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op
Primary outcome [3] 298091 0
Outcome score: Non arthritic hip score
Timepoint [3] 298091 0
Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op
Secondary outcome [1] 306445 0
Outcome Score: EQ5D 5L
Timepoint [1] 306445 0
Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op
Secondary outcome [2] 323150 0
Revision surgery during the observation follow up period due to prosthesis failure
Timepoint [2] 323150 0
2 year follow up

Eligibility
Key inclusion criteria
Male and female >18 years;
radiologically confirmed diagnosis of primary osteoarthritis (OS) of the hip and suitable for primary total hip replacement;
Life expectancy of > 10 years
Receiving a MASTER-SL femoral stem
Voluntary written informed consent obtained
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
Requiring revision hip replacement;
Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip join;
Previous organ transplant;
Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
Body mass index > 40 kg/m2
Active or suspected infection;
Known sensitivity to device materials;
Pregnant woman

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The National Institute for Health and Clinical Excellence (NICE) "benchmark" for hip prostheses is a revision rate of 10% or less over a 10 year period. Data in the current study will be used to determine revision rates for this study population and will be determined using Kaplan-Meier methods. The Orthopaedic Data Evaluation Panel (ODEP) which advises the NHS Supply Chain, require 10 years of followup in at least 500 patients across 3 or more center to be able to classify the evidence for clinical effectiveness of a prosthesis as "strong". Data from this study will support global data to evaluate the ODEP rating for this device.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/10/2014
Date of last participant enrolment
Anticipated
Actual
30/10/2015
Date of last data collection
Anticipated
30/10/2017
Actual
30/10/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7708 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 288578 0
Commercial sector/Industry
Name [1] 288578 0
Lima Orthopaedics Australia Pty Ltd
Country [1] 288578 0
Australia
Primary sponsor type
Other
Name
The Orthopaedic Institute of Queensland (ORIQL)
Address
Suite 102 Level 2 Mater Medical Centre
21-37 Fulham Road
Pimlico QLD 4812
Country
Australia
Secondary sponsor category [1] 287288 0
None
Name [1] 287288 0
Nil
Address [1] 287288 0
Country [1] 287288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290441 0
Mater Hospital Townsville Ethics Committee
Ethics committee address [1] 290441 0
Mater Hospital Townsville
21-37 Fulham Rd
Pimlico QLD 4810
Ethics committee country [1] 290441 0
Australia
Date submitted for ethics approval [1] 290441 0
11/02/2014
Approval date [1] 290441 0
11/02/2014
Ethics approval number [1] 290441 0

Summary
Brief summary
Factors for operative treatment include severity of diseases that affect the hip, symptoms, clinical finding on physical examination and radiological assessment of the hip. When referring to total hip replacement (THR) surgery, both the acetabular socket and the head of the femur are replaced with a suitable prosthetic device consisting of a cup fitted into the acetabulum (socket) and a new head (ball) with stem fitted into the upper shaft of the femur.

Two major factors influence the outcome of THR (outside the surgery process itself) and these are the fixation of the components to the bone and wear of the implanted surfaces. (between the ball and socket). THR is an extremely successful operation due to continuous improvements in surgical techniques, bio-materials and implant design. It is necessary however, to safely evaluate new advances in the design of hip replacement components so that improvements are sought to continually enhance patient outcomes. The design and materials used in the MASTER-SL femoral implant are very similar to other prosthesis already used by surgeons.

The aim of this trial is to assess the clinical performance of the MASTER-SL femoral stem over a two year period under standard condition of use in THR.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 173 173 0 0
/AnzctrAttachments/365639-Hrec approval 16 may 2014.pdf
Attachments [2] 174 174 0 0
/AnzctrAttachments/365639-Section 2 signed ARTG CTN.pdf
Attachments [3] 175 175 0 0
/AnzctrAttachments/365639-Section 4 signed ARTG CTN.pdf
Attachments [4] 176 176 0 0
/AnzctrAttachments/365639-CTN - CID52569 - MHS20140211-3 - 2014 0417 - Mater Health Services Nth Q .pdf

Contacts
Principal investigator
Name 45614 0
Dr Kaushik Hazratwala
Address 45614 0
The Orthopaedic Research Institute of Queensland Suite 102 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
Country 45614 0
Australia
Phone 45614 0
+61 7 47550564
Fax 45614 0
Email 45614 0
[email protected]
Contact person for public queries
Name 45615 0
Mrs Andrea Grant
Address 45615 0
The Orthopaedic Research Institute of Queensland
7 Turner Street, Pimlico, Townsville, QLD Australia. 4812
Country 45615 0
Australia
Phone 45615 0
+61 7 413685331
Fax 45615 0
Email 45615 0
[email protected]
Contact person for scientific queries
Name 45616 0
Mrs Andrea Grant
Address 45616 0
The Orthopaedic Research Institute of Queensland
7 Turner Street, Pimlico, Townsville, QLD Australia. 4812
Country 45616 0
Australia
Phone 45616 0
+61 7 47550564
Fax 45616 0
Email 45616 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Dlaska CE, Jovanovic IA, Grant AL, Graw G, Wilkins... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort-term results of a new self-locking cementless femoral stem: a prospective cohort study of the Lima MasterSL.2021https://dx.doi.org/10.1007/s12306-020-00651-1
N.B. These documents automatically identified may not have been verified by the study sponsor.