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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06108934
Registration number
NCT06108934
Ethics application status
Date submitted
18/10/2023
Date registered
31/10/2023
Date last updated
31/10/2023
Titles & IDs
Public title
A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
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Scientific title
A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
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Secondary ID [1]
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Insignia-23
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Hip stem prosthesis
Experimental: Intervention group - Insignia hip stem study group
Treatment: Devices: Hip stem prosthesis
The Insignia hip stem prosthesis will be used in cementless total hip replacement surgery (THA). The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. Experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Implant survivorship
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Assessment method [1]
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Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.
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Timepoint [1]
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2 years post-operatively
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Secondary outcome [1]
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Oxford Hip Score
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Assessment method [1]
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Performance of the Insignia hip stem using Oxford Hip Score (OHS) in the intervention group
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Timepoint [1]
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Pre-operatively and 6 months, 12 months and 2 years post-operatively
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Secondary outcome [2]
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Hip Disability and Osteoarthritis Outcome Score (HOOS-12).
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Assessment method [2]
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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.
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Timepoint [2]
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Pre-operatively and 6 months, 12 months and 2 years post-operatively
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Secondary outcome [3]
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EQ-5D-5L
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Assessment method [3]
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Function, pain and satisfaction in the intervention group using EQ-5D-5L domains and EQ (Visual analogue scale) VAS. This is a composite measure.
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Timepoint [3]
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Pre-operatively and 6 months, 12 months and 2 years post-operatively
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Secondary outcome [4]
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Hip and lower back pain VAS
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Assessment method [4]
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Hip and lower back pain in the intervention group using a VAS. This is a composite measure.
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Timepoint [4]
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Pre-operatively and 6 months, 12 months and 2 years post-operatively
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Secondary outcome [5]
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Forgotten Joint Score (FJS)
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Assessment method [5]
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Function, pain and satisfaction in the intervention group using Forgotten Joint Score (FJS). This is a composite measure.
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Timepoint [5]
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Pre-operatively and 6 months, 12 months and 2 years post-operatively
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Secondary outcome [6]
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Complications
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Assessment method [6]
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Post-operative complications when the Insignia Hip Stem is used in THA in the intervention group..
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Timepoint [6]
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Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.
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Secondary outcome [7]
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Mortality
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Assessment method [7]
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Mortality in the intervention group
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Timepoint [7]
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1 and 2 years post-operatively
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Secondary outcome [8]
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CPR for stem loosening
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Assessment method [8]
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CPR of the Insignia Hip Stem for stem loosening in the intervention group
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Timepoint [8]
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2 years post-operatively
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Secondary outcome [9]
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Femoral fracture
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Assessment method [9]
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Insignia Hip Stem device-related femoral fracture in the intervention group
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Timepoint [9]
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2 years post-operatively
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/11/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2027
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Actual
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Sample size
Target
313
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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St John of God Subiaco Hospital - Subiaco
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Recruitment postcode(s) [1]
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6008 - Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Stryker Australia Pty Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the survivorship (revision rates) and patient
reported outcomes (PROMs) following implantation of the Insignia hip stem in patients
undergoing cementless total hip replacement surgery compared to currently available stems
used for the same type of surgery.
It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the
benchmark survivorship of similar stems used in the same type of surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06108934
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gavin Clark, MD
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Address
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Perth Hip and Knee
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Eliot Denver
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Address
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Country
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Phone
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+61456630965
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06108934
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