Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000060549
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
23/01/2015
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Date results information initially provided
9/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiographic evaluation of the Paragon femoral stem over 2 years post hip replacement surgery
Scientific title
Prospective clinical trial assessing subsidence and rotation after Paragon hip stem arthroplasty in patients with a primary diagnosis of non-inflammatory degenerative joint disease
Secondary ID [1] 285823 0
Nil
Universal Trial Number (UTN)
Trial acronym
RSA Paragon_RS-11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-inflammatory degenerative joint disease 293738 0
Condition category
Condition code
Musculoskeletal 294037 294037 0 0
Osteoarthritis
Surgery 294038 294038 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing primary total hip replacement and suitable for the cementless Paragon hip stem will be selected. Radiographic visible tantalum beads are inserted around the hip prosthesis during surgery. The procedure adds approx 10 minutes to the standard total hip replacment surgery time.
Intervention code [1] 290800 0
Treatment: Surgery
Intervention code [2] 290801 0
Treatment: Devices
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293815 0
To determine the movement patterns of the Paragon femoral stem for the first 2 years post surgery using radiostereogrammetric analysis.
Timepoint [1] 293815 0
Post-operative at,
6 weeks
6 months
12 months
24 months
Secondary outcome [1] 311923 0
Functional evaluation will be measured pre-operative to post-operative using the Oxford Hip Score.
Timepoint [1] 311923 0
Pre-operative
Post-operative at,
6 weeks
6 months
12 months
24 months
Secondary outcome [2] 311924 0
Health related quality of life evaluation will be measured using the EQ-5D questionnaire.
Timepoint [2] 311924 0
Pre-operative
Post-operative at,
6 weeks
6 months
12 months
24 months

Eligibility
Key inclusion criteria
The individual clinically qualifies for a primary total hip replacment using the Paragon cementless hip stem study prosthesis.
The individual has a primary diagnosis of non-inflammatory degenerative joint disease.
The individual has signed a study specifc informed consent.
The individual is physically and mentally willing and able to comply with pre-operative and post-operative assessments and procedures.
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 to the affected hip joint.
The individual has a neuromuscular or neurosensory deficit which limits the ability to assess the performance of the prosthesis.

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
Completed
Date of first participant enrolment
Anticipated
12/12/2014
Actual
12/12/2014
Date of last participant enrolment
Anticipated
11/12/2015
Actual
10/12/2015
Date of last data collection
Anticipated
10/12/2017
Actual
6/12/2017
Sample size
Target
50
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290384 0
Commercial sector/Industry
Name [1] 290384 0
Global Orthopaedic Technology Pty Ltd
Country [1] 290384 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] 289111 0
None
Name [1] 289111 0
Address [1] 289111 0
Country [1] 289111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292089 0
Nepean Blue Mountains Local Health District HREC
Ethics committee address [1] 292089 0
Ethics committee country [1] 292089 0
Australia
Date submitted for ethics approval [1] 292089 0
Approval date [1] 292089 0
14/11/2014
Ethics approval number [1] 292089 0
11/24

Summary
Brief summary
Radiographic evaluation using RSA method to measure migration and stability of the Paragon femoral stem over 2 years post-surgery.
Functional evaluation using the Oxford Hip Score.
Health related quality of life evaluation using the EQ-5D questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46670 0
A/Prof Rami Sorial
Address 46670 0
Consulting Rooms
60A Derby Street
Penrith, NSW 2750
Country 46670 0
Australia
Phone 46670 0
+61 2 4721 2217
Fax 46670 0
Email 46670 0
[email protected]
Contact person for public queries
Name 46671 0
Mr Lyndon Crossley
Address 46671 0
Global Orthopaedic Technology Pty Ltd
Unit 10, 7 Meridian Place
Baulkham Hills, NSW 2153
Country 46671 0
Australia
Phone 46671 0
+61 2 8887 0115
Fax 46671 0
Email 46671 0
[email protected]
Contact person for scientific queries
Name 46672 0
Mr Lyndon Crossley
Address 46672 0
Global Orthopaedic Technology Pty Ltd
Unit 10, 7 Meridian Place
Baulkham Hills, NSW 2153
Country 46672 0
Australia
Phone 46672 0
+61 2 8887 0115
Fax 46672 0
Email 46672 0
lyndon@globalortho,com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.