Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000318684
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
25/03/2014
Date last updated
14/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of radiographic and clinical outcomes following Absolut femoral prosthesis and Global acetabular cup total hip replacement surgery
Scientific title
Clinical and Radiological Outcome using the Absolut femoral prosthesis and the Global cup system following total hip arthroplasty in patients with Degenerative Joint Disease
Secondary ID [1] 284194 0
Nil
Universal Trial Number (UTN)
Trial acronym
AGC-COP13S
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Joint Disease 291299 0
primary Total Hip Arthroplasty 291429 0
Condition category
Condition code
Surgery 291650 291650 0 0
Other surgery
Musculoskeletal 291651 291651 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective study evaluating post-operative radiology and clinical outcomes in patients who undergo primary total hip replacement using the Absolut femoral stem and Global acetabular cup.

Patients will be recruited over a 2 year period and followed up to 10 years after surgery.

Duration of surgery will be as is standard for total hip arthroplasty.
Intervention code [1] 288890 0
Treatment: Surgery
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291579 0
To evaluate the performance of the Absolut cemented femoral stem with the Global acetabular cup. Patient clinical and radiolographic outcomes will be analysed through 10 years post surgery.
Timepoint [1] 291579 0
Pre-operative, post-operative, 6 weeks, 12 month, 2, 5 and 10 years
Secondary outcome [1] 307111 0
Patient Quality of Life questionnaires, clinical and functional evaluation.

The measurement tools will be:
Assessment of Quality of Life AQoL 6D - a descriptive system of health-related quality of life statements consisting of six dimensions (Independent Living, Mental Health, Coping, Relationships, Pain, Senses) with variable item numbers and response levels.

Oxford Hip - a disease specific assessment tool that evaluates pain, symptoms and function.

Pain Visual Analogue Scale (VAS) - a tool that monitors the patient’s own perception of their pain and its severity.
Timepoint [1] 307111 0
Pre-operative and post-operative at 6 weeks, 12 months, 2, 5, 10 years

Eligibility
Key inclusion criteria
The individual is diagnosed with a primary diagnosis of Degenerative Joint Disease.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-The individual has an active infection within the affected hip joint.
-The individual has had previous total hip replacement or hip fusion of the affected hip joint.
-The individual has a neuromuscular or neurosensory deficit which limits the ability to evaluate safety and effectiveness of the device or has a systemic disease that would affect the subject's welfare or overall outcome of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/03/2014
Actual
20/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2165 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 2166 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [3] 9564 0
St John of God Hospital, Murdoch - Murdoch

Funding & Sponsors
Funding source category [1] 288821 0
Commercial sector/Industry
Name [1] 288821 0
Global Orthopaedic Technology Pty Ltd
Country [1] 288821 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Global Orthopaedic Technology Pty Ltd
Address
Unit 10, 7 Meridian Place
Baulkham Hills, NSW 2153
Country
Australia
Secondary sponsor category [1] 287516 0
None
Name [1] 287516 0
Address [1] 287516 0
Country [1] 287516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295887 0
South Metropolitan Health Service HREC- WA
Ethics committee address [1] 295887 0
Fremantle Hospital. PO 480 Fremantle WA 6959
Ethics committee country [1] 295887 0
Australia
Date submitted for ethics approval [1] 295887 0
05/08/2013
Approval date [1] 295887 0
19/12/2013
Ethics approval number [1] 295887 0
SMHS HREC Ref: 12/239
Ethics committee name [2] 299233 0
St John of God Healthcare HREC
Ethics committee address [2] 299233 0
Level 3, St John of God House
177-179 Cambridge St
Wembley
WA 6014
Ethics committee country [2] 299233 0
Australia
Date submitted for ethics approval [2] 299233 0
08/04/2017
Approval date [2] 299233 0
12/04/2017
Ethics approval number [2] 299233 0
1145

Summary
Brief summary
Fixation of the femoral stem and acetabular shell in their respective bones can be with cement, specialised coatings or a combination of the two (i.e. stem in cement, acetabulum with porous coating), known as hybrid fixation. The cemented Absolut hip stem with the non-cemented Global acetabular cup will be evaluated following primary total hip replacement surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46006 0
Prof Piers Yates
Address 46006 0
Department of Orthopaedic Surgery
Fremantle Hospital,
Alma Street
Fremantle
PO Box 480, WA 6959
Country 46006 0
Australia
Phone 46006 0
+61 8 9431 2260
Fax 46006 0
Email 46006 0
[email protected]
Contact person for public queries
Name 46007 0
Mr Lyndon Crossley
Address 46007 0
Global Orthopaedic Technology
Unit 10, 7 Meridian Place
Baulkham Hills, NSW 2153
Country 46007 0
Australia
Phone 46007 0
+61 2 8887 0115
Fax 46007 0
Email 46007 0
[email protected]
Contact person for scientific queries
Name 46008 0
Mr Lyndon Crossley
Address 46008 0
Global Orthopaedic Technology
Unit 10, 7 Meridian Place
Baulkham Hills, NSW 2153
Country 46008 0
Australia
Phone 46008 0
+61 2 8887 0115
Fax 46008 0
Email 46008 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.