Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000812796
Ethics application status
Approved
Date submitted
18/07/2013
Date registered
24/07/2013
Date last updated
24/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcomes 7 to 10 years following total hip replacement
Scientific title
Dislocation, osteolysis, polyethylene wear, acetabular component migration and other complications 7 to 10 years following randomisation to either a large 36 mm or standard 28 mm diameter metal on highly cross-linked polyethylene articulation in total hip replacement
Secondary ID [1] 282857 0
Nil known
Universal Trial Number (UTN)
U1111-1145-7972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dislocation of total hip replacement 289663 0
Periprosthetic osteolysis 289664 0
Polyethylene wear 289665 0
Acetabular component migration 289666 0
Revision or re-operation of total hip replacement 289667 0
Condition category
Condition code
Musculoskeletal 289986 289986 0 0
Osteoarthritis
Musculoskeletal 289987 289987 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study is a 7 to 10 year follow-up study of patients enrolled in the randomised controlled trial described in ACTRN12609000678291. Patients undergoing total hip replacement were randomised to receive either a large 36 mm articulation (intervention) or standard 28 mm articulation (control).
Intervention code [1] 287548 0
Treatment: Surgery
Intervention code [2] 287550 0
Treatment: Devices
Comparator / control treatment
Patients who, 7-10 years previously, underwent total hip replacement with a standard 28 mm articulation
Control group
Active

Outcomes
Primary outcome [1] 290032 0
% of patients with osteolytic lesions exceeding 1 cubic centimetre, as measured by CT
Timepoint [1] 290032 0
7-10 years following primary total hip replacement
Secondary outcome [1] 303810 0
Incidence of dislocation. Dislocation is measured initially through responses to a Hip Instability Questionnaire and Hospital Visit Questionnaire. Dislocations must then be confirmed radiologically.
Timepoint [1] 303810 0
7 years following total hip replacement
Secondary outcome [2] 303811 0
Polyethylene wear, measured using PolyWare, a computer program which measures wear using plain radiographs
Timepoint [2] 303811 0
7-10 years following total hip replacement
Secondary outcome [3] 303812 0
Acetabular component migration, measured using EBRA (Ein Bild Roentgen Analyse), a computer program which measures migration using plain radiographs
Timepoint [3] 303812 0
7-10 years following total hip replacement
Secondary outcome [4] 303813 0
incidence of re-operation or revision of index total hip replacement
Timepoint [4] 303813 0
7 years following total hip replacement
Secondary outcome [5] 303814 0
Other complications, such as infection, pain and loosening, as reported by patient
Timepoint [5] 303814 0
7 years following total hip replacement

Eligibility
Key inclusion criteria
Only patients involved in the RCT, ACTRN12609000678291, will be eligible for this study
Minimum age
67 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not previously enrolled in the RCT, ACTRN12609000678291

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size is the number of patients still alive and able to undergo follow-up 7-10 years following enrollment in the randomised controlled trial.
Confidence intervals will reflect the available sample size of each analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/03/2010
Actual
24/03/2010
Date of last participant enrolment
Anticipated
15/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 1334 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 1335 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 1336 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [4] 1337 0
St John of God Hospital, Ballarat - Ballarat
Recruitment hospital [5] 1338 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [6] 1339 0
Maroondah Hospital - Ringwood East
Recruitment hospital [7] 1340 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [8] 1341 0
St Andrew's Hospital Inc - Adelaide
Recruitment hospital [9] 1342 0
Glenelg Community Hospital - Glenelg South
Recruitment hospital [10] 1343 0
Modbury Hospital - Modbury
Recruitment hospital [11] 1344 0
Whyalla Hospital - Whyalla
Recruitment outside Australia
Country [1] 5226 0
United Kingdom
State/province [1] 5226 0
England
Country [2] 5227 0
United Kingdom
State/province [2] 5227 0
Scotland

Funding & Sponsors
Funding source category [1] 287631 0
Government body
Name [1] 287631 0
National Health Medical Research Council (NHMRC)
Country [1] 287631 0
Australia
Funding source category [2] 287632 0
Commercial sector/Industry
Name [2] 287632 0
Zimmer
Country [2] 287632 0
United States of America
Primary sponsor type
Individual
Name
Prof Donald Howie
Address
Department of Orthopaedics and Trauma,
Level 4 Bice Building,
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 286377 0
Individual
Name [1] 286377 0
Dr Oksana Holubowycz
Address [1] 286377 0
Department of Orthopaedics and Trauma,
Level 4 Bice Building,
Royal Adelaide Hospital,
North Tce
Adelaide SA 5000
Country [1] 286377 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289601 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 289601 0
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Ethics committee country [1] 289601 0
Australia
Date submitted for ethics approval [1] 289601 0
Approval date [1] 289601 0
13/10/2009
Ethics approval number [1] 289601 0
RAH Protocol No. 090622
Ethics committee name [2] 289602 0
Northern Sydney Central Coast Health (NSCCH) Human Research Ethics Committee
Ethics committee address [2] 289602 0
Research Business Unit
Level 2, Building 51,
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Ethics committee country [2] 289602 0
Australia
Date submitted for ethics approval [2] 289602 0
Approval date [2] 289602 0
13/12/2010
Ethics approval number [2] 289602 0
1011-413M(QA)
Ethics committee name [3] 289603 0
Ballarat Health Services & St John of God Hospital HREC
Ethics committee address [3] 289603 0
Ballarat Health Services
Drummond St N
Ballarat VIC 3350
Ethics committee country [3] 289603 0
Australia
Date submitted for ethics approval [3] 289603 0
Approval date [3] 289603 0
25/05/2011
Ethics approval number [3] 289603 0
HREC/11/BHSSJOG/35
Ethics committee name [4] 289604 0
St Vincent's Hospital (Melbourne) Human Research Ethics Committee-D
Ethics committee address [4] 289604 0
Research Governance Unit
St Vincent's Hospital Melbourne,
Level 5, Aikenhead Bldg,
41 Victoria Pde
Fitzroy VIC 3065
Ethics committee country [4] 289604 0
Australia
Date submitted for ethics approval [4] 289604 0
Approval date [4] 289604 0
23/03/2012
Ethics approval number [4] 289604 0
St Vincent's: HREC-A 001/12; SERP HREC: HREC/12/SVHM/22
Ethics committee name [5] 289605 0
Eastern Health Research and Ethics Committee
Ethics committee address [5] 289605 0
5 Arnold St
Box Hill VIC 3128
Ethics committee country [5] 289605 0
Australia
Date submitted for ethics approval [5] 289605 0
Approval date [5] 289605 0
20/09/2012
Ethics approval number [5] 289605 0
HREC/12/SVHM/22 & Eastern Health Local Ref No: SERP25/1112
Ethics committee name [6] 289606 0
Barwon Health
Ethics committee address [6] 289606 0
Ryrie St
Geelong VIC 3220
Ethics committee country [6] 289606 0
Australia
Date submitted for ethics approval [6] 289606 0
Approval date [6] 289606 0
03/05/2012
Ethics approval number [6] 289606 0
HREC/12/SVHM/22; SSA Ref: SSA/12/VICBH/13; Barwon Health Ref: 12/30

Summary
Brief summary
At 7-10 years after total hip replacement, this study will determine the incidence of bone loss around a primary total hip prosthesis with a metal head and polyethylene liner, as determined by CT, as well as the wear of the polyethylene and the movement of the acetabular cup, as determined by plain radiographs. The study will also examine the incidence of dislocation and other symptoms of hip instability, as well as the reasons for revision or re-operation. In addition, the study will show if there are any differences in these outcomes between prostheses with standard 28 mm and large 36 mm femoral heads.
Trial website
Trial related presentations / publications
Howie DW, Holubowycz OT, Middleton R, The Large Articulation Study Group. Large femoral heads decrease the incidence of dislocation after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2012;94:1095-102.
Public notes

Contacts
Principal investigator
Name 41534 0
Prof Donald Howie
Address 41534 0
Department of Orthopaedics and Trauma,
Level 4, Bice Building,
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 41534 0
Australia
Phone 41534 0
+61 8 8222 5563
Fax 41534 0
Email 41534 0
donald.howie@health.sa.gov.au
Contact person for public queries
Name 41535 0
Dr Oksana Holubowycz
Address 41535 0
Department of Orthopaedics and Trauma,
Level 4, Bice Building,
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 41535 0
Australia
Phone 41535 0
+61 8 8222 5760
Fax 41535 0
Email 41535 0
oksana.holubowycz@health.sa.gov.au
Contact person for scientific queries
Name 41536 0
Dr Oksana Holubowycz
Address 41536 0
Department of Orthopaedics and Trauma,
Level 4, Bice Building,
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 41536 0
Australia
Phone 41536 0
+61 8 8222 5760
Fax 41536 0
Email 41536 0
oksana.holubowycz@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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