Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000811000
Ethics application status
Approved
Date submitted
24/09/2010
Date registered
29/09/2010
Date last updated
20/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective Radiostereometric Analysis (RSA) study of the cementless Total Hip System (CL2 stem / C2 cup) in patients with degenerative hip disease.
Scientific title
A prospective Radiostereometric Analysis (RSA) study to predict long-term safety and effectiveness of the cementless Total Hip System (CL2 stem / C2 cup) in patients with degenerative hip disease.
Secondary ID [1] 252758 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative hip disease 258260 0
Condition category
Condition code
Musculoskeletal 258452 258452 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CL2 is a cementless coated femoral stem made of titanium alloy. The stem tapers proximally to distally in order to achieve fixation within the patient femur, the stem body is 100% hydroxyapatite coated to aid in the biological fixation between the bone and the stem.

The C2-cup is a cementless hemispherical shell made of titanium alloy. The shell has a sintered three-dimensional asymmetric titanium powered coating. The coating is an aid in the biological fixation between the bone and the titanium shell. The plastic liner is manufactured from highly cross-linked high molecular weight polyethylene that is manufactured by a 7.5 Mrad irradiation cycle, melt annealing and subsequent Ethylene Oxide sterilisation. It is manufactured in sizes to accept a 32 & 36mm femoral heads The locking mechanism is a tapered interference fit with locking lugs

Surgical procedure is unilateral. Approximate duration of the surgical procedure time is 70 minutes. Theatre time is 2 hours.
Intervention code [1] 257313 0
Treatment: Surgery
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259285 0
To evaluate the migration of the CL2 cementless femoral stem and the C2 cup in primary total hip replacement using an RSA technique to predict long-term safety and effectiveness of the CL2 stem and C2 cup from early post operative outcomes in small numbers of patients.
Timepoint [1] 259285 0
Subjects will be seen at the 6 month, 1 year, 2 years and 5 years interval post surgery.
Secondary outcome [1] 265709 0
To estimate the clinical complication rates for the cementless CL2 Total Hip System using clinical evaluations for disease specific scores (Oxford hip score) and non-disease specific scores Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) in addition to collation of any adverse events including clinical and radiological underperformance.
Timepoint [1] 265709 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 an cementless total hip system as determined jointly by the surgeon and patient.

2.Have type A or type B femoral bone.

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

4.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
Sex
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
30/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257712 0
Commercial sector/Industry
Name [1] 257712 0
Joint Research Pty Ltd
Country [1] 257712 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Joint Research Pty Ltd
Address
342 Chisholm Road, Auburn NSW 2144
Australia
Country
Australia
Secondary sponsor category [1] 256930 0
None
Name [1] 256930 0
Address [1] 256930 0
Country [1] 256930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259751 0
Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 259751 0
Southern Adelaide Health Service SA Health
Flinders Medical Centre
Flinders Drive, Bedford Pk, 5042,
South Australia
Ethics committee country [1] 259751 0
Australia
Date submitted for ethics approval [1] 259751 0
15/02/2010
Approval date [1] 259751 0
15/05/2010
Ethics approval number [1] 259751 0
65/10

Summary
Brief summary
The aim of this clinical study is to determine the safety and effectiveness of the Cementless Total Hip System (CL2 stem/C2 cup). This will be done by collecting information and data on measured outcomes on the Total Hip System, using the Radiostereometric Analysis (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 31691 0
Prof Jegan Krishnan
Address 31691 0
Department of Orthopaedics, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 31691 0
Australia
Phone 31691 0
+61 08 8204 4289
Fax 31691 0
+61 08 8374 0832
Email 31691 0
jegan.krishnan@flinders.edu.au
Contact person for public queries
Name 14938 0
Mr Mark Balnaves
Address 14938 0
Joint Research Pty Ltd
342 Chisholm Road
Auburn
NSW 2144
Country 14938 0
Australia
Phone 14938 0
+61 (0)457 733 196
Fax 14938 0
Email 14938 0
mbalnaves@evansayers.com.au
Contact person for scientific queries
Name 5866 0
Mr Mark Balnaves
Address 5866 0
Joint Research Pty Ltd
342 Chisholm Road
Auburn
NSW 2144
Country 5866 0
Australia
Phone 5866 0
+ 61 (0) 457 733 196
Fax 5866 0
Email 5866 0
mbalnaves@evansayers.com.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.