MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function

Completed · Not applicable

Conditions studied: Clinical Outcomes

In brief

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.

Key facts

Study ID

NCT03354195

Run by

Foundation for Orthopaedic Research and Education

People needed

14

Starts

2018-07-01

Expected to finish

2020-01-30

Last updated by the study team

2020-02-05

Who can join

Age: 21 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet these criteria to participate in this study:
• Patients with isolated, symptomatic femorotibial knee arthritis and candidates for UKA;
• Patients ≥ 21 years old;
• Patients with intact and non-functional ACLs as determined through pre-operative imaging, knee laxity tests, rotational stability tests, and intraoperative ACL classification;
• Patients willing and able to sign an informed consent;
• Patients willing and able to comply with 2-year follow-up commitments.

You may not qualify if…

• Any subject who meets any of the exclusion criteria will be excluded from participation in this study:
• Patients with RA;
• Patients with BMI >40;
• Patients with ROM arc > 75°;
• Patients with greater than 10º of hyperextension;
• Patients with greater than 15º of varus or valgus deformity;
• Patients with active infection;
• Patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis;
• Patients without sufficient soft tissue integrity to provide adequate stability;
• Patients with either mental or neuromuscular disorders that do not allow control of the knee joint;
• Patients whose weight, age or activity level might cause extreme loads and early failure of the system.

Where it is running

• Florida Orthopaedic Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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