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To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.
The study will collect outcomes data on up to 600 patients from up to 3 sites using a legally marketed device according to its labeled intended use.
The study will collect:
Radiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total knee arthroplasty device | Device | total knee arthroplasty device with ultracongruent bearing surface |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline | Patient-reported outcome measure (PROM) that assesses knee health based on questions about pain, stiffness, function, and daily activities. Minimum score = 0. Maximum score = 100. Higher score means a better outcome. | 1 year postoperative |
| Revision rate | Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components. | 5 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score - change from baseline | A rating scale that measures the outcome of a patient's knee replacement surgery by assessing objective and subjective outcomes, including pain, range of motion, stability, walking distance, and ability to climb stairs, and also patient satisfaction and expectations. Minimum score = 0. Maximum score = 100. Higher score means better outcome. | postoperative intervals through 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seeking primary total knee arthroplasty from the participating surgeon investigators
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| Name | Affiliation | Role |
|---|---|---|
| Brian Schwartz, MD | Illinois Bone & Joint Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoAlabama Spine & Sports | Birmingham | Alabama | 35235 | United States | ||
| Illinois Bone and Joint Institute |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D050723 | Fractures, Bone |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| PROMIS Global Health Score - change from baseline | PROMIS Global Health measures physical function, pain, fatigue, emotional distress, and social health. The raw score minimum is 7 and maximum is 35. Higher score means better outcome. | postoperative intervals through 5 years |
| Surgery Satisfaction Score | Measures a patient's satisfaction with a surgical procedure based on questions about pain control and daily activities. Minimum score is 0. Maximum score is 10. Higher score means better outcome. | 1 and 5 years postoperative |
| Forgotten Joint Score | Measures a patient's awareness of their artificial knee joint. Minimum score is 0. Maximum score is 100. Higher score means better outcome. | postoperative intervals through 5 years |
| Knee Society Roentgenographic Evaluation and Scoring System | Evaluates radiographic signs of device stability. 3 zones are assigned to evaluate the patella component. 5-7 zones are assigned to evaluate the tibia and femur components. Radiolucencies are evaluated for size, location, and progression over time. Changes in implant position and/or radiolucencies that are large, continuous, or progressive over time signify possible or impending implant failure. | Through 2 years postoperative |
| PROMIS Pain Interference Score - change from baseline | The score measures how pain affects a person's life. The raw score minimum is 6 and maximum is 30. A lower score means a better outcome. | postoperative intervals through 5 years |
| PROMIS Physical Function Score - change from baseline | The score measures a person's ability to perform activities. The raw score minimum is 11 and maximum is 72.5. A higher score means a better outcome. | postoperative intervals through 5 years |
| Libertyville |
| Illinois |
| 60048 |
| United States |
| D014947 |
| Wounds and Injuries |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |