A global comparison of Signature Guides and conventional instrumentation in the Oxford partial knee

Completed

• Conditions: joint deterioration; Osteoarthrititis; 10005944

• Registration Number: NL-OMON41709
• Lead Sponsor: BioMet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

-Individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease.
-Patients 21 and over.

Exclusion Criteria

-Active Infection, sepsis or osteomyelitis
-Use of prosthesis in lateral compartment of the knee
-Rheumatoid arthritis or other forms of inflammatory joint disease
-Revision of failed prosthesis, failed upper tibial osteotomy, or post traumatic arthritis after tibial plateau fracture
-Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device.
-Disease or damage to the lateral compartment of the knee
-Patients incapable of following directions regarding rehabilitation
-Patients who refuse, cannot, or should not receive a CT or MRI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint: To determine the accuracy and precision of Signature Guides<br /><br>in the Oxford Knee by the percentage of<br /><br>knees achieving optimal alignment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoint: Average Number of Instrument Cases Used<br /><br>In addition, clinical outcomes and cost efficiency data will be collected to<br /><br>develop economical models.</p><br>