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recruitment difficulty in the centers
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The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOTO medial | Patients suitable fulfilling the standard criteria for the implantation of unicondylar implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOTO Medial | Device | MOTO medial unicompartmental knee system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prosthesis survival | survivorship analysis according to Kaplan-Meier method at 5 years after surgery | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| New Knee Society Score (KSS) | Functionality and symptom of operated knee will be evaluated by New KSS score | preoperative, 3 months, 1, 3 and 5 years |
| Radiological analysis | Postoperative stability and fixation of the device will be assessed by standard radiological exams |
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Inclusion Criteria:
Exclusion Criteria:
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150 patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Zeno Campus Knokke-Heist | Knokke-Heist | 8300 | Belgium | |||
| Clinique Saint-Joseph |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| preoperative, postoperative, 3 months, 1, 3 and 5 years |
| Complication | Intraoperative and postoperative complication will be collected during all duration of the study | up to 5 years |
| Liège |
| 4000 |
| Belgium |
| D013568 |
| Pathological Conditions, Signs and Symptoms |