Oxford Signature vs. Conventional Global Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01763684
First received: November 6, 2012
Last updated: February 27, 2014
Last verified: December 2013
  Purpose

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).


Condition Intervention
Osteoarthritis
Osteoarthritis, Knee
Osteonecrosis
Device: Signature Custom Guides
Procedure: Conventional Instrumentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Percentage of Knees Achieving Optimal Alignment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Number of Instrument Cases Used [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
  • Operative Time [ Time Frame: Immediate Post-Operative ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • Knee Function, Pain, and Range of Motion [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • Radiographic Outcomes [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    1. Mechanical Leg Alignment of Components (degrees)
    2. Radiographic Failure due to either loosening or migration of components will be documented

  • Tourniquet Time [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
  • Implant Sizing [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
  • Blood Loss [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
  • Transfusion Rate [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
  • Use of Cell-Saver [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]
  • Number of Drains Used [ Time Frame: Right after surgery (up to 2 hours after surgery) ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: September 2012
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Signature Custom Guides
Oxford Partial Knee implanted using Signature Custom Guides
Device: Signature Custom Guides
Active Comparator: Conventional Instrumentation
Oxford Partial Knee implanted using Conventional Instrumentation
Procedure: Conventional Instrumentation

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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763684

Contacts
Contact: Kelley McGuire, B.S. (574) 372-1630

Locations
United States, Indiana
Orthopedic and Sports Medicine Center Recruiting
Elkhart, Indiana, United States, 46514
Contact: Kelly Ganz    574-457-3606    kganz@osmc.com   
Principal Investigator: Mark Klaassen, MD         
United States, Maryland
The Orthopaedic Center Recruiting
Rockville, Maryland, United States, 20850
Contact: Chris Broomhead    301-251-1433    cbroomhead@theorthocentermd.com   
Principal Investigator: Joseph Hanna         
United States, Missouri
University of Missouri-Columbia Hospital and Clinics Recruiting
Columbia, Missouri, United States, 65212
Contact: Caleb Cheavens, RN, BSN    573-882-7615    cheavensj@health.missouri.edu   
Principal Investigator: Thomas Aleto, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27703
Contact: Jennifer Friend    919-684-6166    jennifer.friend@duke.edu   
Principal Investigator: Samuel Wellman, MD         
Sub-Investigator: Michael Bolognesi, MD         
United States, Ohio
Joint Implant Surgeons Recruiting
Columbus, Ohio, United States, 43054
Contact: Michael Sneller    614-221-6331 ext 347    snellerMA@joint-surgeons.com   
Principal Investigator: Adolph Lombardi, MD         
Sub-Investigator: Michael Morris, MD         
United States, Texas
Texas Institute for Hip & Knee Surgery Recruiting
Austin, Texas, United States, 78751
Contact: Michele Lebade    512-583-0226    mlabadie@orthoaustin.ecom   
Principal Investigator: Eric Heinrich         
Sub-Investigator: David Dodgin, MD         
United States, Virginia
Advanced Orthopedics Not yet recruiting
Richmond, Virginia, United States, 23294
Contact: Sean Little    804-270-1305 ext 6843    slittle@advancedortho.me   
Principal Investigator: Bradley Ellison, MD         
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Russell Schenck, Ph.D. Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01763684     History of Changes
Other Study ID Numbers: ORTHO.CR.GK7
Study First Received: November 6, 2012
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Australia: Human Research Ethics Committee

Keywords provided by Biomet, Inc.:
Osteoarthritis
Osteoarthritis, Knee
Osteonecrosis
Arthritis
Knee Arthritis
Knee Replacement

Additional relevant MeSH terms:
Osteoarthritis
Osteonecrosis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014