Arthroplasty, Replacement, Knee
Conditions
Keywords
knee, arthroplasty
Brief summary
The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.
Detailed description
The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively. Other outcomes will include knee assessments and patient questionnaires.
Interventions
PROCEDUREVanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide
PROCEDUREVanguard Knee System with conventional Instruments
Vanguard Knee System with conventional Instruments
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more of the knee compartments are involved * correction of varus, valgus or posttraumatic deformity * correction or revision of unsuccessful osteotomy (wedge cut from bone to improve alignment), or arthrodesis (fusion) * need to obtain pain relief and improve function * ability and willingness to follow instructions, including control of weight and activity level. * a good nutritional state * must have reached full skeletal maturity * able and willing to undergo an MRI scan
Exclusion criteria
* infection * sepsis * osteomyelitis * failure of a previous joint replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Axial Alignment | Prior to Discharge: 0-2 weeks | Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome | 6 months, 1 year | American Knee Society Score, Oxford Knee Score |
Countries
Australia, Austria, Belgium, Denmark, France, Netherlands, Portugal, Sweden, United Kingdom, United States
Outcome results
None listed