Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Society Score | Assess knee pain, function and range of motion using the Knee Society Clinical Rating System | Preoperative-2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Outcome Questionnaire | Patient evaluation of function | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The patients eligible for this study are non-inflammatory degenerative joint disease patients requiring a primary unilateral knee surgery. The affected areas must be limited to the medial and patellofemoral compartments.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Center of Vero Beach | Vero Beach | Florida | 32860 | United States | ||
| Orthopaedic Surgery Specialists, Ltd. |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 weeks, 1 year and 2 years |
| Patient Satisfaction | Patient satisfaction questionnaire to be completed at each follow-up visit | 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. | When Necessary |
| Park Ridge |
| Illinois |
| 60068 |
| United States |
| Henry County Center for Orthopedic Surgery & Sports Medicine | New Castle | Indiana | 47362 | United States |
| Iowa Orthopaedic Center, PC | Des Moines | Iowa | 50314 | United States |