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

Completed

• Conditions: knee artrosis; knee wear; 10005944

• Registration Number: NL-OMON36696
• Lead Sponsor: Biomet Nederland BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

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

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* mechanical alignment </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Oxford Knee Score at 1 year post operative.<br /><br>2. American Knee Society Knee Score.<br /><br>3. Radiographic evaluation at each post-operative visit.<br /><br>4. Survivorship at 10 year post-operative.</p><br>