Clinical trial NCT01092312: Signature Personalised Patient Care System With the Vanguard Knee System Study
Official title: Study on the Signature Personalised Patient Care System With the Vanguard Knee System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: knee
arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical Axial Alignment
timeFrame: Prior to Discharge: 0-2 weeks
Secondary outcomes:
measure: Clinical Outcome
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Insall Scott Kelly Institute
state: New York
city: Brisbane
country: Australia
facility: Logan Hospital
state: Queensland
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Grieskirchen
country: Austria
facility: General Hospital Kreuzschwestern
state: Wels
city: Vienna
country: Austria
facility: The Orthopaedic Hospital Speising
city: Brussels
country: Belgium
facility: St Luc General Hospital
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Chambery
country: France
facility: Medipole de Savoie
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Breda
city: Torres Vedras
country: Portugal
facility: Torres Verdras Hospital
state: Lisbon
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Gordon Morrison, MBChB
role: PRINCIPAL_INVESTIGATOR
References: