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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
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.
Orthopedic and Sports Medicine Center
Elkhart, Indiana, United States
The Orthopaedic Center
Rockville, Maryland, United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
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.
Time frame: 12 weeks
Instruments Used During Surgery
Number of Instrument cases used to complete index surgery.
Time frame: Operative
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
Time frame: 1 Year
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
Time frame: Directly Postoperative
Blood Loss
Blood Loss during surgery
Time frame: Right after surgery (up to 2 hours after 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
Time frame: 1 Year
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
Time frame: 1 Year
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Joint Implant Surgeons
Columbus, Ohio, United States
Texas Institute for Hip & Knee Surgery
Austin, Texas, United States
Advanced Orthopedics
Richmond, Virginia, United States
EQ5D Score
EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Time frame: 1 Year
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
Time frame: Directly Postoperative
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
Time frame: Directly Postoperative
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
Time frame: Directly Postoperative