Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000163303
Ethics application status
Not yet submitted
Date submitted
19/03/2008
Date registered
4/04/2008
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimally Invasive Surgery tibial base plate study
Scientific title
Radiostereometric Analysis (RSA), Of The Genesis II Minimally Invasive Surgery (MIS) Tibial Base Plate
Universal Trial Number (UTN)
Trial acronym
MIS Tib
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 2940 0
osteoarthritis 2941 0
Condition category
Condition code
Musculoskeletal 3133 3133 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Genesis II MIS Tibial Base Plate

As the advantages of minimally invasive techniques have become apparent, increasing numbers
of surgeons are seeking to incorporate MIS into their practices – without clinical compromises.
Instrumentation improvement has allowed surgery to be performed through small incisions
with a reduction in soft tissue trauma. The next step in the evolution of MIS lies in the modification
of the implants themselves.
The GENESIS II Minimally Invasive Tibial Baseplate represents the new standard in minimally
invasive implants. Built on the successful implant design history and proven track record of GENESIS,
the MIS baseplate has been specifically designed and tested for minimally invasive techniques.
Available for use with both Cruciate Retaining and Posterior
Stabilized components, the GENESIS II MIS Tibial Baseplate
features a shorter post (20 mm) and fins. This allows easier
insertion through a small incision without tibial subluxation,
resulting in less stress on the incision itself and the extensor
mechanism, as well as less soft tissue trauma.
The MIS baseplate maintains 80% of the GENESIS II baseplate’s fins to ensure that there is no compromise in fixation and
rotational stability.
Intervention code [1] 2675 0
Treatment: Devices
Comparator / control treatment
Standard GENESIS II Tibial base plate

The GENESIS II tibial components
were designed to create solutions
that maximize long-term function
by improving fixation and reducing
osteolysis-causing debris.
The result is a complete set of
implant choices that includes a
nonporous tibial tray and a porous
tibial tray, as well as cruciate
retaining and posterior stabilized
all-poly tibial implants. The improved anatomical shape
combine to maximize cortical
coverage,providing an optimized
foundation for reducing posteromedial
impingement and
polyethylene wear.
The posterior fins have been
enlarged to maximize fixation and
rotational stability of the nonporous
tibial tray. The porous tibial
implant is designed with four
finned spikes, four 6.5 mm cancellous
screws, and the option of a
metaphyseal stem to maximize
initial fixation.8
The proximal surface of the
metal tibial implants is polished to
minimize debris generation at this
articulation surface, while the
dovetail locking mechanism provides
a strong, peripheral lock to
reduce micromotion between the
tray and the articular insert.
Control group
Historical

Outcomes
Primary outcome [1] 3967 0
Radiostereometric Xray analysis
Timepoint [1] 3967 0
6, 12, 24 months
Secondary outcome [1] 6767 0
Patient functional outcome and satisfaction
European quality of life 5 dimensions questionnaire, oxford knee score
Timepoint [1] 6767 0
6, 12 , 24 months

Eligibility
Key inclusion criteria
• 15 physically active subjects diagnosed with osteoarthritis of the knee, who are to undergo total knee replacement surgery
• Informed Consent
Minimum age
0 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Inflammatory or post trauma arthritis
• Earlier High tibial osteotomy (HTO)
• Severe osteoporosis
• Steroid treatment,
• Unclear reason for pain.
• Previous infection.
• Poor understanding of English.
• Body Mass Index >35, > 80 years, < 80° flexion, > 15° Fixed Flexion Deformity or varus/ valgus deformity

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)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3195 0
Self funded/Unfunded
Name [1] 3195 0
Rob Molnar
Country [1] 3195 0
Australia
Primary sponsor type
Individual
Name
Rob Molanr
Address
4 Short St Kogarah nsw 2217
Country
Australia
Secondary sponsor category [1] 2866 0
Individual
Name [1] 2866 0
Rob Molnar
Address [1] 2866 0
4 Short St Kogarah nsw 2217
Country [1] 2866 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5179 0
Ethics committee address [1] 5179 0
Ethics committee country [1] 5179 0
Date submitted for ethics approval [1] 5179 0
20/03/2008
Approval date [1] 5179 0
Ethics approval number [1] 5179 0

Summary
Brief summary
We aim to measure the migration pattern of the tibial base plats using RSA.
We would also like to compare RSA and clinical questionnaire data (oxford knee score and EQ5D score) regarding Genesis II MIS tibial base plate to a previous study involving standard Genesis II tibial base plates
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28449 0
Address 28449 0
Country 28449 0
Phone 28449 0
Fax 28449 0
Email 28449 0
Contact person for public queries
Name 11606 0
Peter Cairns
Address 11606 0
4 Short St Kogarah
Country 11606 0
Australia
Phone 11606 0
0408615126, 95874720
Fax 11606 0
Email 11606 0
pcairns@orthotrauma.com.au
Contact person for scientific queries
Name 2534 0
Rob Molnar
Address 2534 0
4 Short St Kogarah
Country 2534 0
Australia
Phone 2534 0
0402730732, 95874720
Fax 2534 0
Email 2534 0
rmolnar@optusnet.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.