Clinical trial NCT01542580: A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
Official title: A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Post Traumatic Deformity
Complications; Arthroplasty
Deformity of Limb
Keywords: Revision surgery
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prescribed the Vanguard 360 Revision Knee System

Brief summary: The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

Detailed description: This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates:

* Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing
* Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing
* Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe)

The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates.

Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.

Eligibility criteria: Inclusion Criteria:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus or post-traumatic deformity
* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
* Ability and willingness of the patient to attend follow-up visit.
* Willing to give written informed consent
* Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.

Exclusion Criteria:

* infection
* sepsis
* osteomyelitis

Relative Contraindications:

* An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair brain function
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee

Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.

Primary outcomes:
measure: AMERICAN KNEE SOCIETY KNEE SCORE
timeFrame: 24 months postoperative
Secondary outcomes:
measure: Survivorship
timeFrame: 10 years postoperative
Other outcomes:
Locations:
city: Morton Grove
country: United States
facility: Illinois Bone and Joint
state: Illinois
city: Henderson
country: United States
facility: Orthopedic Institute of Henderson
state: Nevada
city: Salt Lake City
country: United States
facility: University of Utah Orthopedic Center
state: Utah
city: Richmond
country: United States
facility: OrthoVirginia West End Orthopedic Clinic
state: Virginia
city: Pellenberg
country: Belgium
facility: University Hopital Pellenberg
city: Aarhus
country: Denmark
facility: Aarhus university hospital
city: Lyon
country: France
facility: Ch Lyon Sud
city: Bad Wildbad
country: Germany
facility: Klinik fur Endoprothetik und gelenkchirurgie
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Terrassa
country: Spain
facility: University Hospital Mutua de Terrasa
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri, PhD
role: STUDY_DIRECTOR
References: