Knee Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
Knee replacement, Knee Osteoarthritis
Brief summary
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population
Detailed description
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.
Interventions
DEVICECementless Vanguard DD RP
Patients treated with the Cementless Vanguard DD RP knee implant
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo primary total knee replacement: * with painful and disabled knee joint resulting from any of the following diagnoses: * Osteoarthritis, * Traumatic arthritis, * Rheumatoid arthritis with one or more compartments involved. * Correction of varus, valgus, or posttraumatic deformity. * Correction or revision of unsuccessful osteotomy or arthrodesis. * 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
* Absolute contraindications include the following diagnoses: * Infection * Osteomyelitis * Previous partial or total prosthetic knee replacement on the operative side * Skeletal immaturity of the patient * Sepsis * Patients who are less than 18 years of age * Relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions, * osteoporosis, * metabolic disorders which may impair bone formation, * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance | 2 years | The performance will be assessed by evaluation of the rate of aseptic loosening of femoral or tibial components within 2 years follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient benefits | 10 years | Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS evaluates both short-term and long-term consequences of knee injury.The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. |
Countries
Austria
Outcome results
None listed