Back to resultsOxford Signature vs. Conventional Global Study
Primary Purpose
Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Signature Custom Guides
Conventional Instrumentation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis, Arthritis, Knee Arthritis, Knee Replacement
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.
Sites / Locations
- Orthopedic and Sports Medicine Center
- The Orthopaedic Center
- University of Missouri-Columbia Hospital and Clinics
- Duke University Medical Center
- Joint Implant Surgeons
- Texas Institute for Hip & Knee Surgery
- Advanced Orthopedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Signature Custom Guides
Conventional Instrumentation
Arm Description
Oxford Partial Knee implanted using Signature Custom Guides
Oxford Partial Knee implanted using Conventional Instrumentation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Instruments Used During Surgery
Number of Instrument cases used to complete index surgery.
Knee Society Functional Score
Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Leg Alignment Femoral Varus/Valgus
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Blood Loss
Blood Loss during surgery
Knee Society Objective Score
Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Oxford Knee Score
Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome
EQ5D Score
EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Leg Alignment Femoral Flexion/Extension
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Leg Alignment Tibial Varus/Valgus
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Leg Alignment Tibial Flexion/Extension
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01763684
Brief Title
Oxford Signature vs. Conventional Global Study
Official Title
A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to slow enrollment and not being able to reach the primary endpoint
Study Start Date
September 2012 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Evaluate the performance & accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation.
Compare the accuracy of Signature Guides between two user profiles: high volume surgeons & low volume surgeons in a global mix.
Assess potential economic & efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis
Keywords
Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis, Arthritis, Knee Arthritis, Knee Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Signature Custom Guides
Arm Type
Active Comparator
Arm Description
Oxford Partial Knee implanted using Signature Custom Guides
Arm Title
Conventional Instrumentation
Arm Type
Active Comparator
Arm Description
Oxford Partial Knee implanted using Conventional Instrumentation
Intervention Type
Device
Intervention Name(s)
Signature Custom Guides
Intervention Description
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
Procedure
Intervention Name(s)
Conventional Instrumentation
Intervention Description
Traditional partial knee arthroplasty without the use of Signature technology.
Primary Outcome Measure Information:
Title
Percentage of Knees Achieving Optimal Alignment
Description
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Instruments Used During Surgery
Description
Number of Instrument cases used to complete index surgery.
Time Frame
Operative
Title
Knee Society Functional Score
Description
Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Time Frame
1 Year
Title
Leg Alignment Femoral Varus/Valgus
Description
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Time Frame
Directly Postoperative
Title
Blood Loss
Description
Blood Loss during surgery
Time Frame
Right after surgery (up to 2 hours after surgery)
Title
Knee Society Objective Score
Description
Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Time Frame
1 Year
Title
Oxford Knee Score
Description
Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome
Time Frame
1 Year
Title
EQ5D Score
Description
EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Time Frame
1 Year
Title
Leg Alignment Femoral Flexion/Extension
Description
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Time Frame
Directly Postoperative
Title
Leg Alignment Tibial Varus/Valgus
Description
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Time Frame
Directly Postoperative
Title
Leg Alignment Tibial Flexion/Extension
Description
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Time Frame
Directly Postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Schenck, Ph.D.
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Orthopedic and Sports Medicine Center
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
The Orthopaedic Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
University of Missouri-Columbia Hospital and Clinics
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Joint Implant Surgeons
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
Texas Institute for Hip & Knee Surgery
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Advanced Orthopedics
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
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Oxford Signature vs. Conventional Global Study
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