Oxford Signature vs. Conventional Global Study

NCT ID: NCT01763684

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-08-31

Brief Summary

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).

Detailed 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:

1. Evaluate the performance & accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation.

2. Compare the accuracy of Signature Guides between two user profiles: high volume surgeons & low volume surgeons in a global mix.

3. Assess potential economic & efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.

Conditions

Osteoarthritis; Osteoarthritis, Knee; Osteonecrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Signature Custom Guides

Oxford Partial Knee implanted using Signature Custom Guides

Group Type: ACTIVE_COMPARATOR

Signature Custom Guides

Intervention Type: DEVICE

Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).

Conventional Instrumentation

Oxford Partial Knee implanted using Conventional Instrumentation

Group Type: ACTIVE_COMPARATOR

Conventional Instrumentation

Intervention Type: PROCEDURE

Traditional partial knee arthroplasty without the use of Signature technology.

Interventions

Signature Custom Guides

Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).

Intervention Type: DEVICE

Conventional Instrumentation

Traditional partial knee arthroplasty without the use of Signature technology.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Schenck, Ph.D.

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Orthopedic and Sports Medicine Center

Elkhart, Indiana, United States

The Orthopaedic Center

Rockville, Maryland, United States

University of Missouri-Columbia Hospital and Clinics

Columbia, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

Joint Implant Surgeons

Columbus, Ohio, United States

Texas Institute for Hip & Knee Surgery

Austin, Texas, United States

Advanced Orthopedics

Richmond, Virginia, United States

Countries

United States

Other Identifiers

ORTHO.CR.GK7

Identifier Type: -

Identifier Source: org_study_id