A Study of Comparing Functional Outcomes after Kinematic and Mechanical Alignment in Total Knee Arthroplasty
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: 13-004207
Sponsor Protocol Number: 13-004207
About this study
The study aim is to conduct a clinical research investigation to compare two alignment techniques used in contemporary total knee arthroplasty by means of a prospective non-randomized clinical trial. The two alignment techniques are Kinematic Alignment (KA) and Mechanical Alignment (MA).
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:
- Primary arthroplasty
- Age between 45 and 80 years old
- Single condylar implant design
Exclusion Criteria:
- Revision arthroplasty
- Age less than 45 and greater than 75 years old
- Pre-operative flexion lower than 90 degrees
- Valgus or varus knee deformity greater than 15 degrees
- The presence of infections, highly communicable diseases (AIDS, active tuberculosis, venereal disease, hepatitis) or metastasis disease
- Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing
- Any congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon’s judgment, interfere with TK prosthesis survival or success
- Presence of previous prosthetic knee or hip replacement device
- BMI > 30
- Pregnant women
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 Mark Pagnano, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available