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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 79 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06670651
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	LinkBio Corp.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	John B Meding, MD
Principal Investigator Affiliation	Indiana Joint Replacement Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis (OA) of the Knee, Fracture, Rheumatoid Arthritis

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OrthoAlabama Spine & Sports, Birmingham, Alabama

Status

Address

OrthoAlabama Spine & Sports

Birmingham, Alabama, 35235

Illinois Bone and Joint Institute, Libertyville, Illinois

Status

Address

Illinois Bone and Joint Institute

Libertyville, Illinois, 60048

Indiana Joint Replacement Institute, Noblesville, Indiana

Status

Address

Indiana Joint Replacement Institute

Noblesville, Indiana, 46060

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