Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000095965
Ethics application status
Approved
Date submitted
25/01/2011
Date registered
28/01/2011
Date last updated
28/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective clinical trial assessing the Nanos short stem femoral prosthesis in patients undergoing total hip replacement surgery
Scientific title
In patients with non-inflammatory joint disease who qualify for total hip replacement (THR) surgery, does insertion of the Nanos short stem femoral component enhance clinical outcomes?
Secondary ID [1] 253477 0
Sir Charles Gairdner Hospital, Perth trial ID
NANOS 2010-090
Universal Trial Number (UTN)
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non inflammatory degenerative joint disease of the hip and the performance of a short stem femoral insert in the setting of total hip replacement surgery. 261026 0
Condition category
Condition code
Musculoskeletal 259166 259166 0 0
Osteoarthritis
Surgery 259179 259179 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A "shorter than usual" femoral component is trialed which requires smaller cuts and therefore less bone loss during THR surgery. THR surgery takes about 2 hours to perform. This implant is inserted into the upper end of the thigh bone and is part of the artificial hip joint. It remains in the body, hopefully for life. However, according to world medical literature, current implants are generally expected to last about 20 years and patients requiring THR surgery are getting younger. Should therefore revision surgery be needed then the bone stock preserving option of the shorter NANOS insert leaves the revision surgeon more options at the time of a second operation.
Intervention code [1] 257913 0
Treatment: Devices
Comparator / control treatment
Prospective trial, results will be compared against known outcome and performance results of long stem femoral components.
Long stem femoral components of varying design have been used worldwide and over more than 40 years ever since Sir Charles Charnley performed pioneering work in the field. Medical world literature contains countless trials and reports on different implants and their performance over this time frame. Over the last 10 to 15 years several countries, including Australia (started in 1999), establish National Joint Replacement Registries which record and track every single implanted device and can therefore serve as a benchmark.
Control group
Historical

Outcomes
Primary outcome [1] 262020 0
The primary objective is to analyse with Roentgen Stereophotogrammetric Analysis (RSA) the migration patterns and rotational stability of the femoral component.
Timepoint [1] 262020 0
6 weeks, 3 months, 1 year, 2 years, 5 years and 10 years post operation
Secondary outcome [1] 268960 0
The secondary objective is to assess the changes in bone formation and resorption using DEXA around the implant . Energy X-ray Absorptiometry (DEXA) has been demonstrated as a reliable method for the determination of bone mineral density of hip implants. This technique provides details about the quality of fixation of the hip prostheses and implant induced bone remodelling.
Timepoint [1] 268960 0
DEXA scan will be completed preoperatively and at 12 months, 24 months, 5 years and 10 years after surgery
Secondary outcome [2] 268999 0
EQ5D surveys will be undertaken.
The EuroQuol Group 5-Dimension Self-Report Questionnaire scores quality of life and is used in medical research. It consists of five questions assessing mobility, self-care, usual activities, pain/discomfort and depression/anxiety and a visual analogue scale for overall perception of health state. It was established as a brief and easy to use instrument and allows self-reporting rather than relying on interview-based assessment tools. Its reliability has been established in various population groups
Timepoint [2] 268999 0
Follow up time points are placed as follows: preoperatively, perioperatively, 1 week, 6 weeks, 3 months, 12 months, 2 years, 5 years and 10 years post operation.
Secondary outcome [3] 269000 0
OHS surveys will be undertaken.
This is a short 12-item questionnaire which patients find easy to complete. It provides reliable and valid data regarding their perception of hip problems
Timepoint [3] 269000 0
Follow up time points are placed as follows: preoperatively, perioperatively, 1 week, 6 weeks, 3 months, 12 months, 2 years, 5 years and 10 years post operation.
Secondary outcome [4] 269002 0
Complications
Complications will be assessed and investigated when radiological or clinical examinations are abnormal and of course when the patient raises concern.
Complications include but are not limited to problems such as wound healing issues, deep or superficial infection, nerve damage, thrombosis or pulmonary embolus, septic or aseptic loosening, dislocations, leg length discrepancy and periprosthetic fractures.
Timepoint [4] 269002 0
Complications will be recorded at any given point in time during the study period.

Eligibility
Key inclusion criteria
6.1 Inclusion Criteria

1. The individual has signed a Patient Informed Consent (“PIC”), specific to this study, and approved by the Institutional Ethics Review Board.
2. The individual is between the ages of 21 and 60 years.
3. The individual is not classified as obese.
4. The individual clinically qualifies for total hip arthroplasty surgery based on physical examination and medical history.
5. The individual is diagnosed with Non Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia).
6. The individual does not have an active infection within the affected hip joint.
7. The individual has not had a previous total hip replacement or hip fusion of the affected hip joint.
8. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse).
9. The individual does not have a neuromuscular nor neurosensory deficiency, which limits the ability to evaluate the safety and effectiveness of the device.
10. The individual does not have a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
11. The individual is skeletally mature.
12. The individual is not pregnant.
13. The individual is not a prisoner.
14. The individual has no plans to relocate to another geographic area before the completion of the study.
Minimum age
21 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
6.2 Exclusion Criteria

1. The individual has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and effectiveness of the device.
2. The individual has any type of radiologically detected osteopenia.
3. The individual has pronounced coxa valga with a femoral neck angle > 145° or coxa vara with a femoral neck angle < 125°.

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)
individuals who qualify for THR and fit the inclusion criteria and are willing to participate will be recruited from our clinics at the hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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
1/06/2011
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] 258390 0
Hospital
Name [1] 258390 0
Sir Charles Gairdner Hospital
Country [1] 258390 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew
Address
Smith & Nephew Pty Limited
Suite 7, 567 Newcastle Street
West Perth
Western Australia 6005
Australia
Country
Australia
Secondary sponsor category [1] 257531 0
None
Name [1] 257531 0
Address [1] 257531 0
Country [1] 257531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260365 0
Ethics Committee at Sir Charles Gairdner Hospital Perth
Ethics committee address [1] 260365 0
Diana Forster
Acting Executive Officer
Human Research Ethics Committee
Executive Corridor
1st Floor 'E' Block
Sir Charles Gairdner Hospital , QE II Medical Centre
Hospital Avenue, NEDLANDS WA 6009
Ethics committee country [1] 260365 0
Australia
Date submitted for ethics approval [1] 260365 0
25/07/2010
Approval date [1] 260365 0
28/10/2010
Ethics approval number [1] 260365 0
NANOS 2010-090

Summary
Brief summary
We propose to undertake a prospective clinical trial assessing qualities of the short stem cementless femoral prosthesis Nanos by Smith & Nephew Pty Ltd. We will undertake a 10 year follow up, which will consist of bone mineral density (“DEXA”) scanning, Roentgenstereometric Analysis (“RSA”), conventional radiographs and functional assessment. Functional analysis will be undertaken by using EuroQuol Group 5-Dimension Self-Report Questionnaire (“EQ5D”) and the Oxford hip score (“OHS”). Follow up time points will include the preoperative visit, the inpatient stay, 6 weeks, 3 months, 12 months and 2 years, 5 years and 10 years post surgery reviews.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32131 0
Address 32131 0
Country 32131 0
Phone 32131 0
Fax 32131 0
Email 32131 0
Contact person for public queries
Name 15378 0
Matt Hofmann
Address 15378 0
Orthopaedic Department
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009, WA
Country 15378 0
Australia
Phone 15378 0
+61 8 9386 3333
Fax 15378 0
Email 15378 0
mahof@hotmail.com
Contact person for scientific queries
Name 6306 0
Mr Riaz Khan, Principal Investigator
Address 6306 0
Suite 8
95 Monash Avenues
Nedlands WA 6009
Country 6306 0
Australia
Phone 6306 0
+61 8 9386 3933
Fax 6306 0
Email 6306 0
rjkkhan@gmail.com

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

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