A Study to Collect Clinical Outcomes in Patients after Knee Arthroplasty
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-011120
Sponsor Protocol Number: 391
About this study
The objective of the study is a multi-center prospective registry to collect clinical outcomes of knee arthroplasty.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Subjects who meet ALL of the following criteria may be included in the study.
- Subjects that are candidates for primary arthroplasty, and will be surgically treated using TKA or UKA prosthesis systems with Vitamin E polyethylene manufactured by Arthrex.
- The subject voluntarily consents to participate in the study and signed the IRB approved informed consent form prior to enrollment
- The subject is eighteen (18) years of age or older
- The subject can comply with all post-operative evaluations, visits, and completion of subjective questionnaires.
- Non inflammatory osteoarthritis
Exclusion Criteria:
Subjects will be excluded from the study if they present with ANY of the following:
- Workman’s compensation cases
- Previous distal femoral or proximal tibial osteotomy including tibial tubercle osteotomy procedure
- Pre-existing hardware that requires removal except cruciate ligament hardware
- BMI > 40
- Varus/Valgus deformity > 15 degrees from mechanical axis
- Blood supply limitations and previous knee infections, which may retard healing
- Foreign body sensitivity
- Conditions that tend to limit the subject's ability or willingness to restrict activities or follow directions during the healing period
- Concomitant procedure with UKA
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Stuart, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available