total knee arthroplasty device
Devicetotal knee arthroplasty device with ultracongruent bearing surface
NCT Number: NCT06670651
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.
Interested in participating?
Request Info18 year–79 year
All sexes
Observational
OrthoAlabama Spine & Sports, Birmingham, Alabama, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
total knee arthroplasty device with ultracongruent bearing surface
Time frame: 1 year postoperative
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.
Time frame: 5 years postoperative
Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.
Time frame: postoperative intervals through 5 years
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.
Time frame: postoperative intervals through 5 years
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.
Time frame: 1 and 5 years postoperative
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.
Time frame: postoperative intervals through 5 years
Measures a patient's awareness of their artificial knee joint. Minimum score is 0. Maximum score is 100. Higher score means better outcome.
Time frame: Through 2 years postoperative
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.
Time frame: postoperative intervals through 5 years
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.
Time frame: postoperative intervals through 5 years
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.
LinkBio Corp.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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