ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Devices

Comparator / control treatment

Unipolar hip replacement

Control group

Active

Outcomes

Primary outcome [1]

Pain, specifically groin pain in observational period as assessed by questionnaire

Timepoint [1]

at 2 weeks and 6 weeks after intervention, +/- 12 weeks depending on patient status.

Primary outcome [2]

Dislocation rates as assessed by questionnaire and xrays

Timepoint [2]

continuous recording until death

Secondary outcome [1]

Harris hip scores which assess the hip

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/02/2012

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)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Orthopaedics and Trauma, Royal Adelaide Hospital

Address [1]

1 North Terrace, Adelaide SA 5000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

11/01/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Assoc Prof Mark Clayer

Address

Department of Orthopaedics and Trauma,
Royal Adelaide Hospital
1 North Terrace, Adelaide SA 5000

Country

Australia

Phone

61 8 8222 0772

Fax

61 8 82323065

mark.clayer@health.sa.gov.au

Contact person for scientific queries

Name

Assoc Prof Mark Clayer

Address

Department of Orthopaedics and Trauma,
Royal Adelaide Hospital
1 North Terrace, Adelaide SA 5000

Country

Australia

Phone

61 8 8222 0772

Fax

61 8 82323065

mark.clayer@health.sa.gov.au

No information has been provided regarding IPD availability

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.

Trial Review

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Documents added manually

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