Finished
MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function
NCT03354195 · Foundation for Orthopaedic Research and Education · Updated 5 Feb 2020
- What is being tested
- Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.
- For
- Clinical Outcomes
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 21 years to 100 years. About 14 people. The full rules are on the registry page.
- Where
- United States
- When
- Starts or started 1 July 2018, ends 30 Jan 2020. Registered 27 Nov 2017.
- Results
- None posted yet.
In the researchers' words
This study represents a single-surgeon/institution, non-randomized, consecutive series, prospective and comparative cohort design. The Principal Investigator is anticipating 100 study patients in the INTACT group and 35 patients in the Anterior Cruciate Ligament-Deficient group.The schedule of events lists the imaging procedures and questionnaires to be completed at each visit. Subjects will be consented and enrolled within 28 days prior to surgery and participate in follow-up visits for two years following their Unicompartmental Knee Arthroplasty. A 3-year enrollment duration is anticipated to enroll a minimum and consecutive series of 25 patients in the experimental Anterior Cruciate Ligament-deficient group. Over the same enrollment duration, 100+ patients with intact Anterior Cruciate Ligaments are expected to be in the control group and undergo Unicompartmental Knee Arthroplasty. The enrollment duration (3 years) and total study duration (5 years) are based on patient volume estimates provided by the Principal Investigator.
Sites
- Florida Orthopaedic InstituteTampa, Florida, United States
