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Enrolling by Invitation

NCT Number: NCT06670651

LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OrthoAlabama Spine & Sports, Birmingham, Alabama, United States

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About this study

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:

  • KOOS-JR
  • Knee Society Score (KSS), 2011
  • PROMIS Global Health
  • PROMIS Physical Function
  • PROMIS Pain Interference
  • Surgery Satisfaction
  • Forgotten Joint Score
  • Radiographic findings
  • Revisions.

Radiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older, and skeletally mature; and
  • Undergoing a primary TKA for one or both knees using the cemented LinkSymphoKnee knee system as part of the surgeon's standard of care.
  • Able to read and understand English (because patient-reported outcome questionnaires are not validated for all potential other languages).

Exclusion criteria

  • 80 years of age or older,
  • Women who are pregnant at the time of surgery,
  • History of joint sepsis,
  • Bone defect that requires grafting,
  • Previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation,
  • Systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation,
  • A poorly functioning contralateral total knee replacement or a contralateral revision regardless of function.

Treatment and study plan

total knee arthroplasty device

Device

total knee arthroplasty device with ultracongruent bearing surface

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline

    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.

  2. Revision rate

    Time frame: 5 years postoperative

    Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.

Secondary outcomes

  1. Knee Society Score - change from baseline

    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.

  2. PROMIS Global Health Score - change from baseline

    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.

  3. Surgery Satisfaction Score

    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.

  4. Forgotten Joint Score

    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.

  5. Knee Society Roentgenographic Evaluation and Scoring System

    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.

  6. PROMIS Pain Interference Score - change from baseline

    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.

  7. PROMIS Physical Function Score - change from baseline

    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.

Sponsors and collaborators

Lead sponsor

LinkBio Corp.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Nov 1, 2024
Registry last updated
Jun 10, 2025

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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