N/A
Completed N=326
Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
Source: ClinicalTrials.gov NCT00753090 ↗Enrolled (actual)
326
Serious AEs
38.3%
Results posted
Jan 2025
Primary outcomePrimary: Knee Society Score — 89.7; 91.8; 89.9; 83.2 score on a scale
Summary
This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Score |
51.2; 53.2; 72.4; 77.5; 81.7; 86.4 | — |
| SECONDARY Knee Society Score |
51.2; 53.2; 72.4; 77.5; 81.7; 86.4 | — |
| SECONDARY Radiographic Evaluation: Total Varus Angle |
3.1; 3.5; 2.9; 3.9; 3.1; 3.9 | — |
| SECONDARY Radiographic Evaluation: Radiolucency |
12; 0; 2; 2; 3; 1 | — |
| SECONDARY Survivorship |
178; 114 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a pre-operative Knee Society Score of = 70
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Patients who are less than 18 years of age
- Sepsis
- Patients who had body mass index >= 40
Relative contraindications include the following factors:
- Uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
- Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis
- 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, or neuromuscular disease in the affected limb.
- Incomplete or deficient soft tissue surrounding the knee
Data sourced from ClinicalTrials.gov (NCT00753090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.