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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Rheumatoid Arthritis; Fracture; Osteoarthritis (OA) of the Knee
• Intervention / Treatment: Device: total knee arthroplasty device

Detailed Description

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:

1. KOOS-JR
2. Knee Society Score (KSS), 2011
3. PROMIS Global Health
4. PROMIS Physical Function
5. PROMIS Pain Interference
6. Surgery Satisfaction
7. Forgotten Joint Score
8. Radiographic findings
9. Revisions.

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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • OrthoAlabama Spine & Sports
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Illinois Bone and Joint Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients seeking primary total knee arthroplasty from the participating surgeon investigators

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rate	Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.	5 years postoperative
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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: LinkBio Corp.
• Investigators: Principal Investigator: Brian Schwartz, MD, Illinois Bone & Joint Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: primary total knee arthroplasty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: LB24001-LSKUC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No