Oxford Signature vs. Conventional Global Study

Last updated: March 29, 2021
Sponsor: Zimmer Biomet
Overall Status: Terminated

Phase

N/A

Condition

Musculoskeletal Diseases

Osteoarthritis

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT01763684
ORTHO.CR.GK7
  • Ages > 21
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 traumaticarthritis after tibial plateau fracture
  • Insufficiency of the collateral, anterior, or posterior cruciate ligaments which wouldpreclude stability of the device.
  • Disease or damage to the lateral compartment of the knee
  • Uncooperative patient or patient with neurologic disorders who is incapable offollowing 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 onroentgenogram
  • 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 arerandomized into treatment groups, all patients must be able to receive an MRI (shouldfollow local MRI screening protocol). This excludes patients who have metal artifactsin the knee, patients who are too large to fit into the knee coil, patients withpacemakers, patients unable to lie still for the duration of the MRI, and patients whoare claustrophobic.

Study Design

Total Participants: 266
Study Start date:
September 01, 2012
Estimated Completion Date:
August 31, 2016

Study 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.

Connect with a study center

  • Orthopedic and Sports Medicine Center

    Elkhart, Indiana 46514
    United States

    Site Not Available

  • The Orthopaedic Center

    Rockville, Maryland 20850
    United States

    Site Not Available

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27703
    United States

    Site Not Available

  • Joint Implant Surgeons

    Columbus, Ohio 43054
    United States

    Site Not Available

  • Texas Institute for Hip & Knee Surgery

    Austin, Texas 78751
    United States

    Site Not Available

  • Advanced Orthopedics

    Richmond, Virginia 23294
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.