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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.
ClinicalTrials.gov, NCT03354195

Sites

  • Florida Orthopaedic InstituteTampa, Florida, United States