Oxford Signature vs. Conventional Global Study

Zimmer Biomet

Status

Terminated

Conditions

Osteoarthritis

Osteonecrosis

Osteoarthritis, Knee

Treatments

Device: Signature Custom Guides

Procedure: Conventional Instrumentation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01763684

ORTHO.CR.GK7

Details and patient eligibility

About

This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons (<10 cases/year).

Full description

The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product:

Evaluate the performance & accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation. Compare the accuracy of Signature Guides between two user profiles: high volume surgeons & low volume surgeons in a global mix. Assess potential economic & efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.

Enrollment

266 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Intended for use in individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease.
Use of cementless femoral fixation is permitted outside of the United States if it complies with all local, state, and/or national and international regulations. The same technique must be used consistently throughout the course of the study with all cases
Patients 21 and over

Exclusion criteria

Use of Cementless Fixation in the United States
Infection, sepsis or osteomyelitis
Use 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
Osteoporosis in the United States / Insufficient bone stock outside the United States
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.