A Study to Collect Clinical Outcomes in Patients after Knee Arthroplasty

Overview

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.

  1. 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.
  2. The subject voluntarily consents to participate in the study and signed the IRB approved informed consent form prior to enrollment
  3. The subject is eighteen (18) years of age or older
  4. The subject can comply with all post-operative evaluations, visits, and completion of subjective questionnaires.
  5. Non inflammatory osteoarthritis

Exclusion Criteria:

Subjects will be excluded from the study if they present with ANY of the following:

  1. Workman’s compensation cases
  2. Previous distal femoral or proximal tibial osteotomy including tibial tubercle osteotomy procedure
  3. Pre-existing hardware that requires removal except cruciate ligament hardware
  4. BMI > 40
  5. Varus/Valgus deformity > 15 degrees from mechanical axis
  6. Blood supply limitations and previous knee infections, which may retard healing
  7. Foreign body sensitivity
  8. Conditions that tend to limit the subject's ability or willingness to restrict activities or follow directions during the healing period
  9. 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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Stuart, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Jennifer Krogman

(507) 538-3562

Krogman.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20425281

Mayo Clinic Footer