Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Zimmer Biomet
- Enrollment
- 113
- Locations
- 2
- Primary Endpoint
- Performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
Performance
Time Frame: 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 Outcomes
- Patient benefits(10 years)