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Enrolling by invitationNCT06670651Updated Sep 3, 2026

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

An observational study in Osteoarthritis (OA) of the Knee, Fracture and Rheumatoid Arthritis, sponsored by LinkBio Corp.. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by LinkBio Corp. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 79 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Osteoarthritis (OA) of the Knee
  • Fracture
  • Rheumatoid Arthritis

Keywords

  • primary total knee arthroplasty
03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's planned enrollment of 600 is above the median of 100 across 601 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with LinkBio Corp. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients seeking primary total knee arthroplasty from the participating surgeon investigators

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Interventions

  • Devicetotal knee arthroplasty device

    total knee arthroplasty device with ultracongruent bearing surface

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year postoperative

  2. Revision rate

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

    Time frame: 5 years postoperative

Secondary outcomes

  1. 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.

    Time frame: postoperative intervals through 5 years

  2. 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.

    Time frame: postoperative intervals through 5 years

  3. 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.

    Time frame: 1 and 5 years postoperative

  4. 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.

    Time frame: postoperative intervals through 5 years

  5. 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.

    Time frame: Through 2 years postoperative

  6. 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.

    Time frame: postoperative intervals through 5 years

  7. 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.

    Time frame: postoperative intervals through 5 years

07

Study locations

2 sites
  • OrthoAlabama Spine & Sports
    Birmingham, Alabama 35235, United States
  • Illinois Bone and Joint Institute
    Libertyville, Illinois 60048, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06670651
Lead sponsor
LinkBio Corp.
Responsible party
Sponsor
First posted
Nov 1, 2024
Start date
Mar 21, 2025
Primary completion
Dec 2031 (estimated)
Completion
Dec 2031 (estimated)
Last update
Sep 3, 2026

Study contacts

Brian Schwartz, MD
principal investigator · Illinois Bone & Joint Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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