This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.
Study Type
OBSERVATIONAL
Enrollment
59
Orthopaedic Center of Vero Beach
Vero Beach, Florida, United States
Orthopaedic Surgery Specialists, Ltd.
Park Ridge, Illinois, United States
Henry County Center for Orthopedic Surgery & Sports Medicine
New Castle, Indiana, United States
Iowa Orthopaedic Center, PC
Des Moines, Iowa, United States
Change in Knee Society Score
Assess knee pain, function and range of motion using the Knee Society Clinical Rating System
Time frame: Preoperative-2 years
Oxford Knee Outcome Questionnaire
Patient evaluation of function
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years
Radiographic Evaluation
X-rays will be assessed for evidence of implant loosening, surface wear, migration or any other clinical or radiographic abnormalities.
Time frame: 6 weeks, 1 year and 2 years
Patient Satisfaction
Patient satisfaction questionnaire to be completed at each follow-up visit
Time frame: 6 weeks, 3 months, 6 months, 1 year and 2 years
Adverse Events
All intra-operative, discharge, and post-operative surgical/hospitalization or study knee-related adverse events will be captured during the study to assess for safety issues.
Time frame: When Necessary
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.