Status:
COMPLETED
MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function
Lead Sponsor:
Foundation for Orthopaedic Research and Education
Collaborating Sponsors:
Stryker Orthopaedics
Conditions:
Clinical Outcomes
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
To compare functional and clinical outcomes in patients with and without intact Anterior Cruciate Ligament undergoing uni-compartmental knee arthroplasty with MAKOplasty Robotic-Arm Assisted Surgery. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03354195
Start Date
July 1 2018
End Date
January 30 2020
Last Update
February 5 2020
Active Locations (1)
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1
Florida Orthopaedic Institute
Tampa, Florida, United States, 33637