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Clinical Evaluation Of Vanguard Deep Dish Rotating Platform Knee Prosthesis

Clinical Evaluation Of Vanguard Deep Dish Rotating Platform Knee Prosthesis - Vanguard Deep Dish

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33907
Enrollment
100
Registered
2009-06-25
Start date
2010-06-04
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arthritis of the knee gonartrosis

Interventions

total knee replacements with either Vanguard Deep Dish rotating platform or Vanguard fixed bearing

Sponsors

Biomet Nederland BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a pre-operative knee score of

Exclusion criteria

Exclusion criteria: Infection. Osteomyelitis. Previous partial or total prosthetic knee replacement on the operative side. Sepsis. Patients who had body mass index >40

Design outcomes

Primary

MeasureTime frame
American Knee Society Score at 2 year postoperative

Secondary

MeasureTime frame
Patient success at 2 year postoperative (see the definition in *Study Definition* section). American Knee Society Score at each postoperative visit. Radiographic evaluation at each postoperative visit. Adverse events. Survivorship at 10 year postoperative. Patient satisfaction as determined by answers to patient outcomes questionnaires Wear using rsa

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)