Osteoarthritis (OA) of the KneeNCT06670651
LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
An observational study of Osteoarthritis (OA) of the Knee and Fracture, run by LinkBio Corp. at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Fracture, Rheumatoid Arthritis
- What is being tested?
- total knee arthroplasty device
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2025to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seeking primary total knee arthroplasty from the participating surgeon investigators
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
OrthoAlabama Spine & Sports
Birmingham, Alabama, 35235
Illinois Bone and Joint Institute
Libertyville, Illinois, 60048
About this study
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:
- 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.
- Being tested
- total knee arthroplasty device
- Keywords
- primary total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Fractures, Bone, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplasty deviceDevice
total knee arthroplasty device with ultracongruent bearing surface
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year postoperative
Revision rate
Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.
Measured: 5 years postoperative
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: postoperative intervals through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start21 Mar 2025
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LinkBio Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Schwartz, MD, Principal investigator, Illinois Bone & Joint Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670651
- Sponsor's protocol ID
- LB24001-LSKUC
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
- ClinicalTrials.gov ID
- NCT06670651
- Acronym / sponsor ID
- LB24001-LSKUC
- Keywords
- primary total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- LinkBio Corp.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking primary total knee arthroplasty from the participating surgeon investigators
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee arthroplasty devicetotal knee arthroplasty device with ultracongruent bearing surface | Device | – |
Primary outcome
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.
Revision rate
Time frame: 5 years postoperative
Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.
7 secondary outcomes
Knee Society Score - change from baseline
Time frame: postoperative intervals through 5 years
PROMIS Global Health Score - change from baseline
Time frame: postoperative intervals through 5 years
Surgery Satisfaction Score
Time frame: 1 and 5 years postoperative
Forgotten Joint Score
Time frame: postoperative intervals through 5 years
Knee Society Roentgenographic Evaluation and Scoring System
Time frame: Through 2 years postoperative
PROMIS Pain Interference Score - change from baseline
Time frame: postoperative intervals through 5 years
PROMIS Physical Function Score - change from baseline
Time frame: postoperative intervals through 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Schwartz, MD principal investigator
Illinois Bone & Joint Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis (OA) of the Knee and Fracture, run by LinkBio Corp. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline (time frame: 1 year postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.