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

Recruitment & Eligibility

Status: Withdrawn

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
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Poor bone quality / known osteoporosis
- Metabolic disorders (which may impair bone formation)
- Osteomalacia
- Distant foci of infections which may spread to implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
- Vascular insufficiency, muscular atrophy, neuromuscular disease.
- Incomplete or deficient soft tissue surrounding the knee.
- Charcot*s disease
- A fixed varus deformity (not passively correctable) of greater than 15 degrees
- A flexion deformity greater than 15 degrees.
- Non-staged Bilateral patients
- Patients who refuse, cannot, or should not receive a CT or MRI. Since patients are randomized into treatment groups, all patients must be able to receive an MRI (should follow local MRI screening protocol). This excludes patients who have metal artifacts in the knee, patients who are too large to fit into the knee coil, patients with pacemakers, patients unable to lie still for the duration of the MRI, and patients who are claustrophobic.

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 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>