The objective of this clinical investigation is to evaluate the safety and effectiveness of the Oxford® Cementless Partial Knee System. The Oxford® Cementless Partial Knee System is intended to help the patients diagnosed with osteoarthritis or avascular necrosis gain mobility and decrease pain. All of the risks common to a conventional joint replacement are possible with this device as certain risks are associated with any invasive procedures. The study is designed to document and compare the clinical and radiographic results of the Oxford® Cementless Partial Knee System to those of the cemented Oxford® Partial Knee System (control treatment).
Prospectively controlled, randomized Investigational study. Patients are asked to come in pre-operatively, surgery, 6 weeks, 6 months, 1 year, 2 years and annually until the last patient reaches their 2 year visit. Product has not been cleared for use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
Oxford Partial Knee applied without bone cement.
Oxford Partial Knee applied with bone cement.
Orthopedic & Sports Medicine Center of Northern Indiana, Inc.
Elkhart, Indiana, United States
Midwest Center for Hip and Knee Surgery
Indianapolis, Indiana, United States
Miller Orthopaedic Affiliates
Council Bluffs, Iowa, United States
Twin City Orthopedics
Edina, Minnesota, United States
OrthoCarolina
Huntersville, North Carolina, United States
Joint Implant Surgeons, Inc
New Albany, Ohio, United States
Texas Center for Joint Replacements
Plano, Texas, United States
Anderson Orthopedic Clinic
Alexandria, Virginia, United States
Radiographic Success
This is a binary endpoint in which a knee is either a "success" or "failure". To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval. 1. Absence of osteolysis 2. No migration/subsidence of any femoral or tibial component 3. Absence of fractured component Conversely, a radiographic failure is defined as follows: 1. Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature. 2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of \> 3 mm as compared to 6 week radiographs. 3. A component fracture
Time frame: 2 years
Absence of Revision/Removal/Unanticipated Adverse Device Effect (UADE)
This is a binary endpoint in which a knee is either a "success" or "failure". To obtain a successful result, a knee must reach the 2 year upper window limit with the device intact and without a component revision/removal or a UADE.
Time frame: 2 Years
The Knee Society Assessment Score
The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Time frame: 2 Years
The Knee Society Function Score
The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Time frame: 2 Year
Knee Society Assessment Score
The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Time frame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Knee Society Score Assessment for Bilateral Subjects
The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Time frame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Knee Society Function Score at All Timepoints
The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Time frame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Knee Society Function Score for Bilateral Subjects
The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Time frame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Oxford Knee Score
* 12-item self-report measure containing questions regarding the patient's pain and level of function * The scoring system ranges from 0-4 on each question with 4 representing maximum function and 0 representing poorest function. * Using this scale, the lowest, worst score is a 0, and the highest, best score is 48. * The OKS has 2 subscales: 1. Pain 2. Function The pain component score (OKS-PCS) consists of items 2, 3, 7, 11 and 12, and the functional component score consists of items 1, 4, 5, 6, 8, 9, and 10.
Time frame: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Number of Knees Which Met the Criteria for Radiographic Success
This is a binary endpoint in which a knee is either a "success" or "failure". To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval. 1. Absence of osteolysis 2. No migration/subsidence of any femoral or tibial component 3. Absence of fractured component Conversely, a radiographic failure is defined as follows: 1. Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature. 2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of \> 3 mm as compared to 6 week radiographs. 3. A component fracture
Time frame: Pre-operation (baseline), 6 weeks, 6 months, 1y, 3y, 4y, 5y, 6y, 7y
Patient Assessment of Satisfaction
At each postoperative assessment using the Analysis Windows, patients were asked to indicate their level of satisfaction with the operated knee. The potential outcomes were Very Satisfied, Satisfied, Uncertain and Unsatisfied.
Time frame: 6 weeks, 6 months, and annually thereafter until study completion
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