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Oxford Signature vs. Conventional Global Study

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ClinicalTrials.gov Identifier: NCT01763684
Recruitment Status : Terminated (Due to slow enrollment and not being able to reach the primary endpoint)
First Posted : January 9, 2013
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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).

Condition or disease Intervention/treatment
Osteoarthritis Osteoarthritis, Knee Osteonecrosis Device: Signature Custom Guides 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
Actual Study Start Date : September 2012
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Signature Custom Guides
Oxford Partial Knee implanted using Signature Custom Guides
Device: 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).
Active Comparator: Conventional Instrumentation
Oxford Partial Knee implanted using Conventional Instrumentation
Procedure: Conventional Instrumentation
Traditional partial knee arthroplasty without the use of Signature technology.



Primary Outcome Measures :
  1. Percentage of Knees Achieving Optimal Alignment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Average Number of Instrument Cases Used [ Time Frame: Right after surgery (up to 2 hours after surgery) ]
  2. Operative Time [ Time Frame: Immediate Post-Operative ]
  3. Patient Satisfaction [ Time Frame: 10 Years ]
  4. Knee Function, Pain, and Range of Motion [ Time Frame: 10 Years ]
  5. Radiographic Outcomes [ Time Frame: 1 Year ]
    1. Mechanical Leg Alignment of Components (degrees)
    2. Radiographic Failure due to either loosening or migration of components will be documented

  6. Tourniquet Time [ Time Frame: Right after surgery (up to 2 hours after surgery) ]
  7. Implant Sizing [ Time Frame: Right after surgery (up to 2 hours after surgery) ]
  8. Blood Loss [ Time Frame: Right after surgery (up to 2 hours after surgery) ]
  9. Transfusion Rate [ Time Frame: Right after surgery (up to 2 hours after surgery) ]
  10. Use of Cell-Saver [ Time Frame: Right after surgery (up to 2 hours after surgery) ]
  11. Number of Drains Used [ Time Frame: Right after surgery (up to 2 hours after surgery) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763684


Locations
United States, Indiana
Orthopedic and Sports Medicine Center
Elkhart, Indiana, United States, 46514
United States, Maryland
The Orthopaedic Center
Rockville, Maryland, United States, 20850
United States, Missouri
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27703
United States, Ohio
Joint Implant Surgeons
Columbus, Ohio, United States, 43054
United States, Texas
Texas Institute for Hip & Knee Surgery
Austin, Texas, United States, 78751
United States, Virginia
Advanced Orthopedics
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Russell Schenck, Ph.D. Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01763684     History of Changes
Other Study ID Numbers: ORTHO.CR.GK7
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Keywords provided by Zimmer Biomet:
Osteoarthritis
Osteoarthritis, Knee
Osteonecrosis
Arthritis
Knee Arthritis
Knee Replacement

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