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Trial registered on ANZCTR


Registration number
ACTRN12610000853044
Ethics application status
Approved
Date submitted
24/09/2010
Date registered
13/10/2010
Date last updated
24/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective Radiostereometric Analysis (RSA) study of the cemented Total Hip System (E2 stem/ P2 cup) in patients with degenerative hip disease
Scientific title
A prospective Radiostereometric Analysis (RSA) study to predict long -term safety and effectiveness of the cemented Total Hip System (E2 stem/ P2 cup) in patients with degenerative hip disease
Secondary ID [1] 252752 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative hip disease 258253 0
Condition category
Condition code
Musculoskeletal 258442 258442 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The E2 stem is a cemented femoral device made of chrome-cobalt alloy. The stem has a double tapered geometry to aid the taper- slip theory of cement fixation.

The P2-cup is an all-polyethylene acetabular component intended for cemented fixation. The polyethylene cup is manufactured from highly cross-linked polyethylene that is manufactured by a 7.5Mrad irradiation cycle, melt annealing and subsequent ethylene oxide sterilisation. It is manufactured in sizes to accept 32mm and 36mm diameter femoral heads.

Surgical procedure is unilateral. Approximate duration of the surgical procedure time is 70 minutes. Theatre time is 2 hours.
Intervention code [1] 257270 0
Treatment: Surgery
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259281 0
To evaluate the migration of the E2 Cemented femoral stem and the P2 all-poly cup, in primary cemented total hip replacement using an RSA technique to predict long-term safety and effectiveness of each hip system component from early post operative outcomes in a small cohort of patients.
Timepoint [1] 259281 0
Subjects will be seen at the 6 month, 1 year, 2 years and 5 years interval post surgery
Primary outcome [2] 259400 0
To evaluate the in-vivo wear of the P2 cup, in primary cemented total hip replacement using an RSA technique to determine polyethylene wear rates per annum in 3 directions.
Timepoint [2] 259400 0
Subjects will be seen at the 6 month, 1 year, 2 years and 5 years interval post surgery
Secondary outcome [1] 265702 0
To estimate the clinical complication rates for the Cemented E2 Total Hip System using clinical evaluations for disease specific scores (Oxford Hip Score) and non-disease specific scores Hip Dysfunction and Oestoarthritis Outcome Score(HOOS) in addition to collation of any adverse events including clinical and radiological underperformance.
Timepoint [1] 265702 0
Subjects will be seen at the 6 month, 1 year, 2 years and 5 years interval post surgery

Eligibility
Key inclusion criteria
1.Patient requires unilateral primary total hip arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/ developmental dysplasia of the hip (DDH) who are candidates for a Cemented Total Hip System as determined jointly by the surgeon and patient.

2.Male and non-pregnant female patients aged 18 to 75

3.Patients who understand the conditions of the study and are willing and able to give written informed consent to participate in the length of the study including prescribed follow-ups.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patient has active infection or sepsis (treated or untreated)

2.Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.

3.Patient is female of child-bearing age and not taking contraceptive precautions

4.Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis).

5.Patient has inflammatory joint disease (e.g. rheumatoid arthritis)

6.Patient has known moderate to severe renal insufficiency.

7.Patient has a known or suspected metal sensitivity.

8.Patient is immunosuppressed with diseases such as acquired immunodeficiency syndrome (AIDS) or receiving high doses of corticosteroids.

9.Patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the Clinical Evaluation including mental illness, mental retardation, or drug, alcohol abuse.

10.Patient is severely overweight. Body Mass Index BMI > 40.

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
N/A
Phase
Not Applicable
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)

Funding & Sponsors
Funding source category [1] 257711 0
Commercial sector/Industry
Name [1] 257711 0
Joint Research Pty Ltd
Address [1] 257711 0
342 Chisholm Road, Auburn NSW 2144
Country [1] 257711 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Joint Research Pty Ltd
Address
342 Chisholm Road, Auburn NSW 2144
Country
Australia
Secondary sponsor category [1] 256928 0
None
Name [1] 256928 0
Address [1] 256928 0
Country [1] 256928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259750 0
Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 259750 0
Southern Adelaide Health Service SA Health
Flinders Medical Centre
Flinders Drive, Bedford Park
South Australia 5042
Ethics committee country [1] 259750 0
Australia
Date submitted for ethics approval [1] 259750 0
15/02/2010
Approval date [1] 259750 0
15/05/2010
Ethics approval number [1] 259750 0
67/10

Summary
Brief summary
The aim of this clinical study is to determine the safety and effectiveness of the cemented Total Hip System (E2 stem/P2 cup). This will be done by collecting information and data on measured outcomes on the Total Hip System, using RSA method to provide early results on the implant. The intended use of this implant is for patients with degenerative joint disease who require a primary total hip replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31688 0
Prof Jegan Krishnan
Address 31688 0
Department of Orthopaedics, Flinders Medical Centre, Flinders Drive,
Bedford Park SA 5042
Country 31688 0
Australia
Phone 31688 0
+61 08 8204 4289
Fax 31688 0
Email 31688 0
jegan.krishnan@flinders.edu.au
Contact person for public queries
Name 14935 0
Mr Anthony Switzer
Address 14935 0
Joint Research Pty Ltd
342 Chisholm Road
Auburn
NSW 2144
Country 14935 0
Australia
Phone 14935 0
+61 (0)457 733 196
Fax 14935 0
Email 14935 0
a.switzer@jointresearch.com.au
Contact person for scientific queries
Name 5863 0
Mr Anthony Switzer
Address 5863 0
Joint Research Pty Ltd
342 Chisholm Road
Auburn
NSW 2144
Country 5863 0
Australia
Phone 5863 0
+61 (0)457 733 196
Fax 5863 0
Email 5863 0
a.switzer@jointresearch.com.au

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