Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000294651
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
20/03/2014
Date last updated
18/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical outcome study following Total Hip Replacement using the Paragon femoral stem and Global acetabular cup prostheses
Scientific title
A Multi-centre, Prospective, Consecutive Series, Clinical Outcomes Study to evaluate the safety and performance of the Paragon Hip Stem and Global Acetabular Cup prostheses combination following primary Total Hip Arthroplasty in patients with non-Inflammatory Degenerative Joint Disease
Secondary ID [1] 283974 0
Nil
Universal Trial Number (UTN)
Trial acronym
PGC-COP13S
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-Inflammatory Degenerative Joint Disease 291001 0
primary Total Hip Arthroplasty 291427 0
Condition category
Condition code
Surgery 291347 291347 0 0
Other surgery
Musculoskeletal 291649 291649 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective study to evaluate radiological and clinical outcomes in patients who undergo primary total hip replacement surgery, using the Paragon femoral stem and Global acetabular cup.
It follows the investigators standard practice for total hip arthroplasty. Surgical duration will be the same as for routine total hip replacement surgery.
Intervention code [1] 288658 0
Treatment: Devices
Intervention code [2] 288659 0
Treatment: Surgery
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291340 0
Evaluate the safety and performance of the Paragon femoral stem and the Global acetabular cup. Patient clinical and radiographic outcomes will be analysed through 2 years post surgery.
Timepoint [1] 291340 0
Pre-operative, 1 week, 6 weeks, 6 months and 2 years
Secondary outcome [1] 306557 0
Patient Quality of Life and clinical and functional evaluation will be measured using the,

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 Score - a disease specific assessment that evaluates hip pain, symptoms and related function.
Pain Visual Analogue Scale (VAS) - a simple assessment tool consisting of a horizontal 100 mm line, where the endpoints are labelled ‘no pain’, and ‘extreme pain’ that the patient places a vertical line through the horizontal line to monitor their own perception of their pain and its severity.
Timepoint [1] 306557 0
Pre-operative, 6 weeks, 6 months and 2 years

Eligibility
Key inclusion criteria
-The individual clinically qualifies for primary total hip arthroplasty surgery.
-The individual is diagnosed with a primary diagnosis of non-Inflammatory Degenerative Joint Disease.
-The individual is physically and mentally willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Minimum age
21 Years
Maximum age
85 Years
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 a 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
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/03/2014
Actual
6/06/2014
Date of last participant enrolment
Anticipated
Actual
30/03/2016
Date of last data collection
Anticipated
30/03/2018
Actual
Sample size
Target
70
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288654 0
Commercial sector/Industry
Name [1] 288654 0
Global Orthopaedic Technology Pty Ltd
Country [1] 288654 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] 287365 0
None
Name [1] 287365 0
Address [1] 287365 0
Country [1] 287365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295888 0
Nepean Blue Mountains Local health District HREC
Ethics committee address [1] 295888 0
Court Building , Ground Floor, PO Box 63, Penrith. NSW 2751
Ethics committee country [1] 295888 0
Australia
Date submitted for ethics approval [1] 295888 0
07/06/2013
Approval date [1] 295888 0
11/09/2013
Ethics approval number [1] 295888 0
HREC/13/NEPEAN/78

Summary
Brief summary
The Paragon hip stem and the Global acetabular cup non-cemented prostheses will be evaluated following primary total hip replacement surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45414 0
A/Prof Rami Sorial
Address 45414 0
Consulting Rooms
60a Derby Street
Penrith, NSW 2750
Country 45414 0
Australia
Phone 45414 0
+61 2 4721 2217
Fax 45414 0
Email 45414 0
[email protected]
Contact person for public queries
Name 45415 0
Mr Lyndon Crossley
Address 45415 0
Global Orthopaedic Technology
Unit 10, 7 Meridian Place
Baulkham Hills, NSW 2153
Country 45415 0
Australia
Phone 45415 0
+61 2 8887 0115
Fax 45415 0
Email 45415 0
[email protected]
Contact person for scientific queries
Name 45416 0
Mr Lyndon Crossley
Address 45416 0
Global Orthopaedic Technology
Unit 10, 7 Meridian Place
Baulkham Hills, NSW 2153
Country 45416 0
Australia
Phone 45416 0
+61 2 8887 0115
Fax 45416 0
Email 45416 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.