Signature Personalised Patient Care System With the Vanguard Knee System Study
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
325 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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