Study Stopped
Due to slow enrollment and not being able to reach the primary endpoint
Oxford Signature vs. Conventional Global Study
A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
1 other identifier
interventional
266
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
January 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
April 23, 2021
CompletedApril 23, 2021
March 1, 2021
3.9 years
November 6, 2012
January 28, 2021
March 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Knees Achieving Optimal Alignment
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
12 weeks
Secondary Outcomes (10)
Instruments Used During Surgery
Operative
Knee Society Functional Score
1 Year
Leg Alignment Femoral Varus/Valgus
Directly Postoperative
Blood Loss
Right after surgery (up to 2 hours after surgery)
Knee Society Objective Score
1 Year
- +5 more secondary outcomes
Study Arms (2)
Signature Custom Guides
ACTIVE COMPARATOROxford Partial Knee implanted using Signature Custom Guides
Conventional Instrumentation
ACTIVE COMPARATOROxford Partial Knee implanted using Conventional Instrumentation
Interventions
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).
Traditional partial knee arthroplasty without the use of Signature technology.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (7)
Orthopedic and Sports Medicine Center
Elkhart, Indiana, 46514, United States
The Orthopaedic Center
Rockville, Maryland, 20850, United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212, United States
Duke University Medical Center
Durham, North Carolina, 27703, United States
Joint Implant Surgeons
Columbus, Ohio, 43054, United States
Texas Institute for Hip & Knee Surgery
Austin, Texas, 78751, United States
Advanced Orthopedics
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Meijer, Clinical Operations Manager
- Organization
- Zimmer Biomet
Study Officials
- STUDY DIRECTOR
Russell Schenck, Ph.D.
Zimmer Biomet
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2012
First Posted
January 9, 2013
Study Start
September 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
April 23, 2021
Results First Posted
April 23, 2021
Record last verified: 2021-03