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Trial registered on ANZCTR


Registration number
ACTRN12612000051842
Ethics application status
Not yet submitted
Date submitted
10/01/2012
Date registered
11/01/2012
Date last updated
11/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparitive study of a mobile bearing hip system with unipolar hip replacement in patients requiring a unipolar hip replacement for metastatic bone disease.
Scientific title
Does using a mobile bearing hip replacement reduce post-operative pain compared to a unipolar hip replacement in patients requiring a unipolar hip replacement for metastatic bone disease.
Secondary ID [1] 279703 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic bone disease affecting the proximal femur 285536 0
Condition category
Condition code
Cancer 285728 285728 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 Unipolar hip replacement which is a hip replacement that replaces only the femoral side
Arm 2 Mobile bearing hip replacement which is a hip replacement that replaces the femoral side and lines the acetabulum
These procedures take from 30 -120 minutes to do differing on a case by case basis.
Intervention code [1] 283997 0
Treatment: Devices
Comparator / control treatment
Unipolar hip replacement
Control group
Active

Outcomes
Primary outcome [1] 286254 0
Pain, specifically groin pain in observational period as assessed by questionnaire
Timepoint [1] 286254 0
at 2 weeks and 6 weeks after intervention, +/- 12 weeks depending on patient status.
Primary outcome [2] 286255 0
Dislocation rates as assessed by questionnaire and xrays
Timepoint [2] 286255 0
continuous recording until death
Secondary outcome [1] 295453 0
Harris hip scores which assess the hip
Timepoint [1] 295453 0
12 weeks

Eligibility
Key inclusion criteria
Metastatic disease involving the proximal femur that requires surgical replacement of the femoral head
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not fit for surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are referred to the Specialist Clinic for consideration for joint replacement by other specialists. Those deemed needing a unipolar joint replacement to treat their disease will be offered to participate in the trial.
Patients will be allocated a unique record number by the hospital administrator which is independent of the investigator.
Those with an even record number will get the standard unipolar hip replacement, those with an odd number will get the mobile bearing hip replacement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The hospital administrator has generated 40 random numbers that will be assigned to the patients as they present in consecutive order. Those ending in an even number will be selected for the unipolar control goup, those with an odd number will be allocated to the mobile bearing group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 284484 0
Hospital
Name [1] 284484 0
Department of Orthopaedics and Trauma, Royal Adelaide Hospital
Address [1] 284484 0
1 North Terrace, Adelaide SA 5000
Country [1] 284484 0
Australia
Primary sponsor type
Hospital
Name
Department of Orthopaedics and Trauma, Royal Adelaide Hospital
Address
1 North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 283408 0
None
Name [1] 283408 0
Address [1] 283408 0
Country [1] 283408 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286464 0
Ethics committee address [1] 286464 0
Ethics committee country [1] 286464 0
Date submitted for ethics approval [1] 286464 0
11/01/2012
Approval date [1] 286464 0
Ethics approval number [1] 286464 0

Summary
Brief summary
This study aims to assess whether a mobile bearing hip replacement will reduce the incidence of groin pain compared to that experienced with a unipolar hip replacement without an increased risk of dislocation. Who is it for? You may be eligible for this study if you have been diagnosed with metastatic disease that has spread to the proximal femur – thigh bone – which requires surgical replacement of the femoral head. Trial Details In this study, you will receive either a Unipolar hip replacement which is a hip replacement that replaces only the femoral side, or a Mobile bearing hip replacement which is a hip replacement that replaces the femoral side and lines the acetabulum, the socket of the pelvis. Following either of these interventions, you will then be assessed through the use of questionnaires and x-rays. Metastatic bone disease may affect only the proximal femoral side of the hip joint. Conventional surgical treatment consists of a unipolar hip replacement because the acetabulum is not affected and total hip replacement in this situation has been associated with an increased risk of hip dislocation. Unipolar hip replacements have a much lower risk of dislocation but the articulating surface consists of a metallic head against articular cartilage of the acetabulum. This always results in degradation of the articular surface of the acetabulum and pain. A new device, the ADMX3 mobile bearing hip system (Stryker, NJ, USA) is derived from a dual mobility cup concept which has a proven track record of decreased dislocation and increased implant stability. Instead of the metallic head grinding into the acetabular cartilage, this system is a two-piece component with an acetabular cup that replaces the articular surface into which a polyethylene insert is added into which the metallic head of the proximal femur is inserted. This results in articulation both between the head and insert and the insert and the acetabular cup, not against articular cartilage. This system also has a notch in the anterior portion of the cup which reduces the risk of cup and iliopsoas tendon impingement which is also a source of groin pain post hip replacement. Theoretically it should therefore reduce pain and not increase the risk of dislocation but it is not known if it will improve the incidence or severity of post-operative groin pain that is associated with a unipolar or bipolar hip replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33614 0
Address 33614 0
Country 33614 0
Phone 33614 0
Fax 33614 0
Email 33614 0
Contact person for public queries
Name 16861 0
Assoc Prof Mark Clayer
Address 16861 0
Department of Orthopaedics and Trauma,
Royal Adelaide Hospital
1 North Terrace, Adelaide SA 5000
Country 16861 0
Australia
Phone 16861 0
61 8 8222 0772
Fax 16861 0
61 8 82323065
Email 16861 0
mark.clayer@health.sa.gov.au
Contact person for scientific queries
Name 7789 0
Assoc Prof Mark Clayer
Address 7789 0
Department of Orthopaedics and Trauma,
Royal Adelaide Hospital
1 North Terrace, Adelaide SA 5000
Country 7789 0
Australia
Phone 7789 0
61 8 8222 0772
Fax 7789 0
61 8 82323065
Email 7789 0
mark.clayer@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results