Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.
Detailed description
This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study. The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
Interventions
DEVICEVanguard CR
The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.
DEVICEAGC knee
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
Sponsors
East Sussex Hospitals NHS Trust
Biomet U.K. Ltd.
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-op knee score of \<70 * Scheduled to undergo primary total knee replacement with any of the following indication: 1. pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis. 2. One or more compartments involved. * Need to obtain pain relief and improve function * Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations * A good nutritional state of the patient * Full skeletal maturity of the patient, patients who are at least 18 years of age. * Patients of either sex * Consent form read, understood, and signed by patient
Exclusion criteria
* Pre-op knee score greater than or equal to 70 * Infection * Osteomyelitis * Previous partial or total prosthetic knee replacement on the operative side * Skeletal immaturity of the patient, patients who are less than 18 years of age. * Sepsis * Uncooperative patient or patient with neurological disorders who are incapable of following directions * Osteomalacia * Distant foci of infections * Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb * Incomplete or deficient soft tissue surrounding the knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Knee Society Knee Score | 2 year | Objective scoring system to rate the knee and patient's functional abilities before and after TKA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Knee Society Score, Oxford Knee-12, SF-12 | 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y | Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires |
| Radiographic evaluation | 6m,1y, 2y, 3y, 5y, 10y | Assessment of patient x-rays |
| Patient success | 2 year | Defined as Knee Score greater than or equal to 80, No component revisions or removals, No pending component revisions or removals, Absence of osteolysis, No migration/subsidence of \>3mm or \>3 degrees |
| Survivorship | 10 years | Implant survivorship based on removal of a study device. |
| Noble & Weiss Knee Score, Kujala Score | 6w, 6m, 1y, 2y | Scoring systems based on patient questionnaires |
| Adverse Events | any | Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. |
Countries
United Kingdom
Outcome results
None listed