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A Comparison of Signature Guides and Conventional Techniques with the Vanguard Knee System

A Comparison of Signature Guides and Conventional Techniques with the Vanguard Knee System - Vanguard signature

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36696
Enrollment
44
Registered
2011-11-21
Start date
2012-02-02
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

knee artrosis knee wear

Interventions

None listed

Sponsors

Biomet Nederland BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Painful and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis or Traumatic Arthritis where one or more compartments are involved 2. Correction of varus, valgus or post traumatic deformity 3. Need to obtain pain relief and improve function 4. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations 5. Good nutritional state of the patient 6. Full skeletal maturity of the patient 7. Patients are at least 18 years of age 8. Patients of either sex 9. Consent form read, understood, and signed by patient. 10. Able to obtain MRI

Exclusion criteria

Exclusion criteria: 1. Absolute contraindications include: infection, sepsis, osteomyelitis and a previous joint replacement.

Design outcomes

Primary

MeasureTime frame
* mechanical alignment

Secondary

MeasureTime frame
1. Oxford Knee Score at 1 year post operative. 2. American Knee Society Knee Score. 3. Radiographic evaluation at each post-operative visit. 4. Survivorship at 10 year post-operative.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)