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Trial registered on ANZCTR


Registration number
ACTRN12613000335796
Ethics application status
Approved
Date submitted
23/03/2013
Date registered
26/03/2013
Date last updated
24/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of cemented and uncemented fixation of primary total hip replacement
Scientific title
In persons older than 50 undergoing total hip replacement surgery for primary osteoarthritis, is there any difference in hip pain and function at two years and longer-term follow-up with cemented versus cementless prosthesis fixation?
Secondary ID [1] 282168 0
Nil
Universal Trial Number (UTN)
U1111-1140-9894
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
primary osteoarthritis of the hip 288681 0
Condition category
Condition code
Musculoskeletal 289027 289027 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Uncemented total hip replacement surgery with a cobalt-chrome alloy porous coated hemispherical PCA acetabular component with two lateral fixation lugs for supplementary fixation (Howmedica International, London) and a collarless cobalt chrome alloy PCA femoral stem with sintered porous beads coating the proximal one third of the stem circumferentially (Howmedica International, London), performed using standard surgical tehniques and a posterior surgical approach. Patients monitored regularly following the procedure by clinical and radiographic review, including at 2 years for primary study hypothesis and over the long-term until revision of the components, death or lost-to-follow-up.
Intervention code [1] 286776 0
Treatment: Surgery
Intervention code [2] 286777 0
Treatment: Devices
Comparator / control treatment
Cemented total hip replacement surgery with an all-polyethylene or metal-backed ultrahigh molecular weight polyethylene Exeter acetabular component (Howmedica International, London) and a collarless double tapered polished stainless steel Exeter stem (Howmedica International, London), performed using standard surgical techniques and a posterior surgical approach. Patients monitored regularly following the procedure by clinical and radiographic review, including at 2 years for primary study hypothesis and over the long-term until revision of the components, death or lost-to-follow-up.
Control group
Active

Outcomes
Primary outcome [1] 289142 0
Hip pain and function, defined by the Harris hip score (Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. J Bone Joint Surg. 1969;51A:737-55)
Timepoint [1] 289142 0
The primary outcome will be assessed at 2 years after surgery to test the primary hypothesis
Secondary outcome [1] 301916 0
Hip pain and function, defined by the Harris Hip Score, over long term follow-up after surgery
Timepoint [1] 301916 0
Review periods following surgery 5 year, 8 year, 11 year, 15 year, 20 year, 25 year
Secondary outcome [2] 301917 0
Radiographic loosening as assessed from plain X-rays based on migration of prostheses and presence of radiolucencies. Measurements of prosthesis position and change in position over time (migration) made using templates adjusted for magnification. Radiographic loosening was determined using the classification systems of Hodgkinson for the acetabular components (Hodgkinson JP et al. Clin Orthop Rel Res.1988; 228:105-9) and Harris and Malchau for the cemented stems (Harris WH et al. J Bone Joint Surg.1982;64A:1063-7; Malchau H et al. Acta Orthop Scand. 1995;66:418-24.) and Engh for the uncemented stems (Engh CA et al. Clin Orthop Rel Res. 1988;235:91-110).
Timepoint [2] 301917 0
Review periods following surgery 5 year, 11 year, 15 year, 20 year, 25 year
Secondary outcome [3] 301918 0
Radiographic osteolysis defined off plain X-ray as an area of bone that appeared less radio-dense than the surrounding bone, with a border clear enough that it could be outlined according to Engh (Engh AC et al J Arthroplasty. 2002;17:752-9)
Timepoint [3] 301918 0
Review periods following surgery 5 year, 11 year, 15 year, 20 year, 25 year
Secondary outcome [4] 301919 0
Prosthesis survival to endpoint revision total hip replacement surgery requiring removal of prostheses for loosening confirmed at surgery. All reoperations documented prospectively to determine months to revision surgery and reason for revision. Survival analysis is undertaken using Kaplan-Meier methods.
Timepoint [4] 301919 0
At longest time point when a minimum of 20 hips continue to be followed up (ie have not been censored out of the study due to patient death, lost to follow-up or removal of the prosthesis at revision total hip replacement surgery)
Secondary outcome [5] 301920 0
Prosthesis survival to endpoint revision total hip replacement surgery requiring removal of prostheses for reasons other than loosening confirmed at surgery. This includes, but not restricted to, infection, bone fracture around the prosthesis, hip instability. All reoperations documented prospectively to determine months to revision surgery and reason for revision. Survival analysis is undertaken using Kaplan-Meier methods.
Timepoint [5] 301920 0
At longest time point when a minimum of 20 hips continue to be followed up (ie have not been censored out of the study due to patient death, lost to follow-up or removal of the prosthesis at revision total hip replacement surgery)

Eligibility
Key inclusion criteria
Diagnosis of primary osteoarthritis of hip
Minimum age of 50 years
Aged less than 72 for males and 77 for females which were the population age cut-offs for a life expectancy of at least 10 years as of the start of the trial.
Minimum age
50 Years
Maximum age
77 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery or trauma to the hip
Previous infection of the hip
Paget’s disease
Acetabular dysplasia
Known allergy to cobalt-chrome
Medical conditions with resultant life expectancy of less than 10 years
Unable to attend regular outpatient reviews for at least two years.

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)
The study was undertaken as a parallel-arm RCT. All patients planned for primary THA by two senior consultant surgeons were screened for inclusion. Consenting patients were randomized preoperatively to undergo either cemented total hip replacement with the Exeter prostheses or uncemented total hip replacement with the PCA prosthesis, using a pre-prepared, non-concealed randomization sequence, and an allocation ratio of 1:1.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intraoperative inclusion criteria included availability of suitably sized prostheses at surgery and, for the uncemented group, excellent fit of the femoral stem, defined as less than a 2mm gap between the stem and cortical bone determined by visual inspection, no interface movement following insertion of the trial component and subjective assessment of good fit and fill on an intraoperative radiograph.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: To test the hypothesis, a minimum of 30 patients per group were required to detect a difference of 20 out of a possible 100 points (0.2) of the Harris Hip Score 14, as determined by independent samples test with adjustment for non-parametric analysis, effect size 0.66, power 0.8, alpha 0.05. Minimum sample size was increased by 33% to 40 per group to allow for longer follow-up and unanticipated death or loss to follow-up.
Statistical analyses: Mann-Whitney U test was used to compare the Harris hip score between the groups at two years.
Linear mixed effects models were used to compare Harris hip scores over time between the groups.
Logistic generalised estimating equations were used to compare the odds of a good Harris hip pain score (44 or 40) over time between groups. Variable effect predictors were preoperative age, gender, body mass index and Charnley grade, and, for the cemented group, metal backing of the acetabular component and femoral head modularity.
Kaplan-Meier survival analysis was performed using the endpoint major revision. The logrank test was used to compare survival curves.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/1986
Actual
2/06/1986
Date of last participant enrolment
Anticipated
Actual
3/08/1992
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
80
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 788 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 789 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6602 0
5000 - Adelaide
Recruitment postcode(s) [2] 6601 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 286936 0
Charities/Societies/Foundations
Name [1] 286936 0
The Adelaide Bone and Joint Research Foundation
Country [1] 286936 0
Australia
Funding source category [2] 286937 0
Charities/Societies/Foundations
Name [2] 286937 0
The Australian Orthopaedic Association Research Fund
Country [2] 286937 0
Australia
Funding source category [3] 286938 0
University
Name [3] 286938 0
Flinders University of South Australia
Country [3] 286938 0
Australia
Funding source category [4] 286939 0
Charities/Societies/Foundations
Name [4] 286939 0
Royal Australasian College of Surgeons
Country [4] 286939 0
Australia
Funding source category [5] 286940 0
Hospital
Name [5] 286940 0
Royal Adelaide Hospital Research Fund
Country [5] 286940 0
Australia
Primary sponsor type
Individual
Name
Professor Donald W Howie
Address
Department of Orthopaedics and Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285725 0
None
Name [1] 285725 0
None
Address [1] 285725 0
None
Country [1] 285725 0
Other collaborator category [1] 277329 0
Individual
Name [1] 277329 0
Mr Colin Steele-Scott
Address [1] 277329 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country [1] 277329 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288992 0
Flinders Medical Centre Ethics Committee
Ethics committee address [1] 288992 0
Ethics committee country [1] 288992 0
Australia
Date submitted for ethics approval [1] 288992 0
Approval date [1] 288992 0
04/12/1985
Ethics approval number [1] 288992 0
113/85

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38690 0
Prof Donald W
Address 38690 0
Department of Orthopaedics & Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 38690 0
Australia
Phone 38690 0
+61 8 8222 5563
Fax 38690 0
Email 38690 0
donald.howie@health.edu.au
Contact person for public queries
Name 38691 0
Margaret McGee
Address 38691 0
Department of Orthopaedics & Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 38691 0
Australia
Phone 38691 0
+61 8 8222 4079
Fax 38691 0
Email 38691 0
margaret.mcgee@adelaide.edu.au
Contact person for scientific queries
Name 38692 0
Donald Howie
Address 38692 0
Department of Orthopaedics & Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 38692 0
Australia
Phone 38692 0
+61 8 8222 5563
Fax 38692 0
Email 38692 0
donald.howie@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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