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Trial registered on ANZCTR


Registration number
ACTRN12623000391673
Ethics application status
Approved
Date submitted
24/03/2023
Date registered
18/04/2023
Date last updated
18/10/2023
Date data sharing statement initially provided
18/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, pre-market, multi-center study of the Insignia hip stem in total hip replacement surgery to determine implant survivorship (revision rate) and patient reported outcome measures (PROMs).
Scientific title
A prospective, pre-market, multi-center evaluation of the clinical outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
Secondary ID [1] 309295 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary non-inflammatory degenerative joint disease 329403 0
Condition category
Condition code
Musculoskeletal 326350 326350 0 0
Osteoarthritis
Musculoskeletal 326351 326351 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Insignia hip stem prosthesis will be used in cementless THA surgery. The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components.

There are seven hospitals in Australia participating in this study. Seven experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis.
Intervention code [1] 325685 0
Treatment: Surgery
Intervention code [2] 325686 0
Treatment: Devices
Comparator / control treatment
The Insignia stem will be compared to;
1) All other hip stems (Registry benchmark),
2) Modern cementless hip stems (Class benchmark) and
3) Modern, collared cementless hip stems (like-for-like comparator).

Comparator data will be collected from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR).
.
Comparators will be historically collected AOANJRR surgeries since it was established in 1999 until the conclusion of the study period.
Control group
Active

Outcomes
Primary outcome [1] 334201 0
Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.

This data will be collected via the AOANJRR records and data-linkage to medical records.
Timepoint [1] 334201 0
2 years following the primary THA surgery
Secondary outcome [1] 419826 0
Performance of the Insignia hip stem using Oxford Hip Score (OHS) in the intervention group
Timepoint [1] 419826 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [2] 419827 0
Function, pain and satisfaction in the intervention group using the Hip Disability and Osteoarthritis Outcome Score mid-version (HOOS-12). This is a composite measure.
Timepoint [2] 419827 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [3] 419828 0
Function, pain and satisfaction in the intervention group using EQ-5D-5L domains and EQ (Visual analogue scale) VAS. This is a composite measure.
Timepoint [3] 419828 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [4] 419829 0
Hip and lower back pain in the intervention group using a VAS. This is a composite measure.
Timepoint [4] 419829 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [5] 419830 0
Function, pain and satisfaction in the intervention group using Forgotten Joint Score (FJS). This is a composite measure.
Timepoint [5] 419830 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [6] 419992 0
Post-operative complications when the Insignia Hip Stem is used in THA in the intervention group..

For example, wound infection, blood clots, reaction to medication, heart attack, stroke, chest infection or pneumonia, fracture around your hip.

These will be assessed via adverse event reporting, study-specific questionnaires administered via the AOANJRR online tool, clinical examination by the Surgeon Investigators at follow-up consultations and data-linkage to medical records..
Timepoint [6] 419992 0
Collect throughout the study if/when they arise
Secondary outcome [7] 419993 0
Mortality in the intervention group
Timepoint [7] 419993 0
1 and 2 years post-operatively
Secondary outcome [8] 419994 0
CPR of the Insignia Hip Stem for stem loosening in the intervention group

This data will be collected via the AOANJRR records and data-linkage to medical records.
Timepoint [8] 419994 0
2 years post-operatively
Secondary outcome [9] 420475 0
Insignia Hip Stem device-related femoral fracture in the intervention group

This data will be collected via the AOANJRR records and data-linkage to medical records.
Timepoint [9] 420475 0
2 years post-operatively

Eligibility
Key inclusion criteria
• The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device
• Primary non-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis
• The patient is a candidate for a primary cementless THA.
• Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Active or suspected latent infection in or about the affected hip joint and the time of study device implantation.
• Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post-operative care.
• Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
• Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. >30 days.)
• Requires revision THA or hip fusion to the affected joint.
• Has known sensitivity to device materials.
• Any involvement in an active Workers’ Compensation investigation

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
313
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 313402 0
Commercial sector/Industry
Name [1] 313402 0
Stryker Australia Pty Ltd
Country [1] 313402 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Pty Ltd
Address
8 Herbert Street
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 315213 0
None
Name [1] 315213 0
Address [1] 315213 0
Country [1] 315213 0
Other collaborator category [1] 282590 0
Commercial sector/Industry
Name [1] 282590 0
Australian Orthopaedic Association National Joint Replacement Registry
Address [1] 282590 0
SAHMRI
North Terrace
Adelaide SA 5000
Country [1] 282590 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312620 0
Sydney Local Health District Ethics Review Committee (RPAH Zone) EC00113
Ethics committee address [1] 312620 0
Ethics committee country [1] 312620 0
Australia
Date submitted for ethics approval [1] 312620 0
24/04/2023
Approval date [1] 312620 0
23/06/2023
Ethics approval number [1] 312620 0
Ethics committee name [2] 312649 0
St John of God Health Care Human Research Ethics Committee EC00286
Ethics committee address [2] 312649 0
Ethics committee country [2] 312649 0
Australia
Date submitted for ethics approval [2] 312649 0
03/07/2023
Approval date [2] 312649 0
10/08/2023
Ethics approval number [2] 312649 0

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

Contacts
Principal investigator
Name 125310 0
Dr Gavin Clark
Address 125310 0
Perth Hip and Knee
1/1 Wexford Street
Subiaco WA 6008
Country 125310 0
Australia
Phone 125310 0
+61 08 6489 1777
Fax 125310 0
Email 125310 0
clark@hipnknee.com.au
Contact person for public queries
Name 125311 0
Eliot Denver
Address 125311 0
Stryker Australia Pty Ltd
8 Herbert Street
St Leonards NSW 2065
Country 125311 0
Australia
Phone 125311 0
+61 0456 630 965
Fax 125311 0
Email 125311 0
eliot.denver@stryker.com
Contact person for scientific queries
Name 125312 0
Eliot Denver
Address 125312 0
Stryker Australia Pty Ltd
8 Herbert Street
St Leonards NSW 2065
Country 125312 0
Australia
Phone 125312 0
+61 0456 630 965
Fax 125312 0
Email 125312 0
eliot.denver@stryker.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.