Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000855527
Ethics application status
Approved
Date submitted
25/06/2024
Date registered
10/07/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
10/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A 2 year clinical study to compare the clinical results of a new design to existing designs of an acetabular hip cup aimed to resist dislocation while allowing normal motion, after joint replacement surgery for patients suffering a fracture of the neck of the femur.
Scientific title
A registry-nested study of the Inovaris Constrained Dual Mobility Acetabular Cup for patients receiving total joint replacement treatment for a fractured neck of femur.
Secondary ID [1] 312399 0
027INO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured neck of femur 334209 0
Dislocation following total hip arthroplasty 334286 0
Condition category
Condition code
Musculoskeletal 330874 330874 0 0
Other muscular and skeletal disorders
Injuries and Accidents 330873 330873 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following a fractured neck of femur, patients agreeing to participate in the study will undergo surgery by a trained Orthopaedic surgeon for implantation of a polyethylene liner within a cobalt-chrome liner, which is inserted into a titanium outer shell fitted into the acetabulum. The inner liner has a containment mechanism that provides full movement with secure constraint at the terminal range. This is mated with a new or existing standard femoral stem and head that completes the joint replacement. This is a single procedure taking approximately 1 to 2 hours. Patients will be assessed immediately post-operatively and subsequently their medical records will be further reviewed and assessed at 30 days, 1 year and 2 years.
Intervention code [1] 328904 0
Rehabilitation
Intervention code [2] 328902 0
Treatment: Devices
Comparator / control treatment
Modern dual mobility or conventional acetabular prostheses in current use since 2021, implanted as a total hip arthroplasty for fractured neck of femur recorded in the AOA National Joint Replacement Registry between December 2000 and December 2024.
Control group
Historical

Outcomes
Primary outcome [1] 338630 0
Revision surgery for any reason.
Timepoint [1] 338630 0
2 years following primary surgery.
Secondary outcome [1] 436723 0
Revision surgery for dislocation.
Timepoint [1] 436723 0
Participant will be contacted and reviewed at 30 days, 1 year and 2 years following primary surgery.
Secondary outcome [2] 436725 0
Death.
Timepoint [2] 436725 0
30 days, 1 year and 2 years following primary surgery.
Secondary outcome [3] 436724 0
Revision surgery for any reason.
Timepoint [3] 436724 0
1 year following primary surgery.
Secondary outcome [4] 436726 0
Complications as a result of the surgery or associated treatment including admission for infection; dislocation; stiffness; fracture; wound dehiscence; implant loosening, migration or failure; wound bleeding; other non-joint surgery; reoperation on the same joint for the same reasons.
Timepoint [4] 436726 0
At any time during 2 years post original surgery, and specifically at 30 days, 1 year and 2 years.

Eligibility
Key inclusion criteria
Patients with displaced femoral neck fracture suitable for standard total hip arthroplasty.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to walk independently pre-fracture.
Dementia or significant cognitive impairment.
Permanent resident of aged care facility.
Pathological femoral fracture.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 316807 0
Commercial sector/Industry
Name [1] 316807 0
R R Medical Pty Ltd
Country [1] 316807 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
R R Medical Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319033 0
None
Name [1] 319033 0
Address [1] 319033 0
Country [1] 319033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315577 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315577 0
Ethics committee country [1] 315577 0
Australia
Date submitted for ethics approval [1] 315577 0
23/06/2024
Approval date [1] 315577 0
02/10/2024
Ethics approval number [1] 315577 0
REGIS ID 2024/ETH01322

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

Contacts
Principal investigator
Name 135134 0
Dr Neil Bergman
Address 135134 0
c/- AOA NJRR SAHMRI North Terrace, Adelaide, SA 5000
Country 135134 0
Australia
Phone 135134 0
+61 417307794
Fax 135134 0
Email 135134 0
[email protected]
Contact person for public queries
Name 135135 0
RR Medical Pty Ltd
Address 135135 0
c/- AOA NJRR SAHMRI North Terrace, Adelaide, SA 5000
Country 135135 0
Australia
Phone 135135 0
+61 08 8128 4280
Fax 135135 0
Email 135135 0
[email protected]
Contact person for scientific queries
Name 135136 0
AOA NJRR
Address 135136 0
c/- AOA NJRR SAHMRI North Terrace, Adelaide, SA 5000
Country 135136 0
Australia
Phone 135136 0
+61 08 8128 4280
Fax 135136 0
Email 135136 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Will be available to people who have ethical or other approvals to use the data sets, and as approved by the data custodian.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Non-identifiable final data sets for Primary outcome.

What types of analyses could be done with individual participant data?
• Will be available for analyses that reflect the original intent of the data collection, and have appropriate ethical or other approvals in place.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available once results have been published. No end date will be in place.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Will be supplied by the data custodian, AOANJRR if approved by RR Medical Pty. Ltd. Information about the data set, including a DOI, will be publicly available once data set is available. The AOA NJRR is published annually. AOA NJRR SAHMRI North Terrace, Adelaide, SA 5000, [email protected].

Are there extra considerations when requesting access to individual participant data?
No


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.