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Sponsor election
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The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latella Knee Implant System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latella Knee Implant System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant | 6 Months | |
| Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in knee outcome measures (KOOS, IKDC, NRS) | 6, 12 and 24 months | |
| Device and procedure complication rates | 6, 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manoj Ramachandran, MD | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slotervaart Hospital | Amsterdam | Netherlands | ||||
| Amphia Ziekenhuis |
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| Breda |
| Netherlands |
| St. Anna Hospital | Geldrop | Netherlands |
| University Hospital Maastricht | Maastricht | Netherlands |
| Isala | Zwolle | Netherlands |
| Hospital Clinic | Barcelona | Spain |
| Hospital Vall d'Hebron | Barcelona | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Fundacion Jimenez Diaz | Madrid | Spain |
| Royal London Hospital | London | United Kingdom |
| Norfolk & Norwich University Hospital | Norwich | United Kingdom |
| Morriston Hospital | Swansea | United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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