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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.
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] 0 0
Insignia-23
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA)) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant survivorship
Timepoint [1] 0 0
2 years post-operatively
Secondary outcome [1] 0 0
Oxford Hip Score
Timepoint [1] 0 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [2] 0 0
Hip Disability and Osteoarthritis Outcome Score (HOOS-12).
Timepoint [2] 0 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [3] 0 0
EQ-5D-5L
Timepoint [3] 0 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [4] 0 0
Hip and lower back pain VAS
Timepoint [4] 0 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [5] 0 0
Forgotten Joint Score (FJS)
Timepoint [5] 0 0
Pre-operatively and 6 months, 12 months and 2 years post-operatively
Secondary outcome [6] 0 0
Complications
Timepoint [6] 0 0
Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.
Secondary outcome [7] 0 0
Mortality
Timepoint [7] 0 0
1 and 2 years post-operatively
Secondary outcome [8] 0 0
CPR for stem loosening
Timepoint [8] 0 0
2 years post-operatively
Secondary outcome [9] 0 0
Femoral fracture
Timepoint [9] 0 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
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
313
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06108934
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gavin Clark, MD
Address 0 0
Perth Hip and Knee
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eliot Denver
Address 0 0
Country 0 0
Phone 0 0
+61456630965
Fax 0 0
Email 0 0
eliot.denver@stryker.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06108934