A Study of Patient Satisfaction Comparing Medial Constrained Versus Posterior Stabilized Total Knee Arthroplasty from a Single Design
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 21-012001
About this study
The purpose of this study is to determine if medically contained (MC) total knee arthoplasty (TKA) achieves similar patient satisfaction at 1-year follow-up compared to posterior stabilized (PS) TKA.
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:
- Evaluation for total knee arthroplasty (TKA) at Mayo Clinic (Rochester, MN) or OrthoCarolina (Charlotte, NC).
- Evaluated and scheduled for TKA at Mayo Clinic by Drs. Cody Wyles, Robert Trousdale, Kevin Perry, Corey Couch, or Nic Bedard or at OrthoCarolina by Drs. Thomas Fehring, Bo Mason, Keith Fehring, or Jesse Otero.
- Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery.
- ≥ 18 years of age at enrollment.
Exclusion Criteria:
- Previous surgery with hardware on the joint of interest.
- Varus or valgus defor 1mity > 15° or any other preoperative deformity at the discretion of the surgeon portending a risk of needing a constrained or hinged device.
- Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease).
- BMI ≥ 40.
- Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol.
- Contralateral side previously enrolled in this study (i.e., simultaneous bilateral or staged bilateral patients cannot have both sides enrolled).
- Current tobacco use.
Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.
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 Cody Wyles, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available