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Minimally Invasive Surgery tibial base plate study

Radiostereometric Analysis (RSA), Of The Genesis II Minimally Invasive Surgery (MIS) Tibial Base Plate

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000163303
Acronym
MIS Tib
Enrollment
15
Registered
2008-04-04
Start date
2008-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 represen

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.

Sponsors

Rob Molanr
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 80 Years
Healthy volunteers
Yes

Inclusion criteria

• 15 physically active subjects diagnosed with osteoarthritis of the knee, who are to undergo total knee replacement surgery • Informed Consent

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026