The purpose of this study is to demonstrate that the Uniglide™ Mobile Bearing Unicondylar Knee System (investigational device)is not inferior when compared to the Uniglide™ Fixed Bearing Unicondylar Knee System (control device currently cleared) as measured by the Composite Clinical Success (CCS) endpoint.
Arthritic knees are the most common cause of long-term disability resulting in decreased mobility and increased pain. After other treatments for pain relief and return to activities of daily living fail, knee joint replacement is often the best option and unicompartmental knee arthroplasty was introduced as an appropriate treatment for management of osteoarthritis when disease effects only a portion of the knee joint. This study is a prospective, comparative, randomized, double blind (patient and post-operative evaluator), multi-center clinical study under a common protocol to determine the safety and effectiveness of the Uniglide Unicondylar Mobile Bearing knee implant system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo)that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo)tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
S.T.A.R. Orthopaedics, Inc.
La Quinta, California, United States
Orthopaedic Associates of West Florida
Clearwater, Florida, United States
Bluegrass Orthopaedics and Hand Care
Lexington, Kentucky, United States
Texas Orthopedic Specialists
Bedford, Texas, United States
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.
CCS success criteria includes the following: Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement; No radiographic failure: No radiolucent lines \>1mm in \>50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) \> 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations \> 2 degrees; No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery.
Time frame: Month 24 postoperative
American Knee Society Score (AKSS) (Total, Pain & Function Scores)
American Knee Society Score (AKSS) Total Score - Range: 0 (worst) - 100 (best) Pain Score - Range: 0 (worst) - 50 (best) Function Score - Range: 0 (worst) - 100 (best)
Time frame: Month 24 postoperative
Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)
HSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best)
Time frame: Month 24 postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
Knee injury and Osteoarthritis Outcome Score (pain): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (symptoms): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (activities of daily living (ADL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport/rec): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life (QOL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport and recreation): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life): 0 (worst) - 100 (best)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Memorial Bone & Joint
Houston, Texas, United States
Texas Center for Joint Replacement
Plano, Texas, United States
Time frame: Month 24 postoperative
Survival Rate Using Kaplan-Meier Survival Curves
Kaplan-Meier survival curves will be plotted for All Enrolled investigational devices and All Enrolled control devices on the same graph to facilitate graphical comparisons of survivorship over time.
Time frame: Month 24 postoperative
Number of Implants With Any Device-related Complications
Time frame: Month 24 postoperative
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
For both the Tibial \& Femoral Components the following were recorded: Implant Subsidence \> 2mm (recorded for the tibial component only) Implant Loosening \> 2deg Radiolucent Line (RLL) in \>50% zones Progressive RLL Osteolysis ≥ 5mm
Time frame: Month 24 postoperative