Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
Not Applicable
Terminated
- Conditions
- Osteoarthritis
- Registration Number
- NCT02343705
- Lead Sponsor
- Cotera, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 67
Inclusion Criteria
- History of pain due to medial osteoarthritis
- Qualifying baseline pain scores
- Kellgren-Lawrence Grades 2-3
Exclusion Criteria
- Osteoporosis
- Rheumatoid arthritis
- Joint instability
- Metal ion allergy
- Permanent implant in or around the knee joint
- Prior anterior cruciate ligament reconstruction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Device and procedure complication rates 6, 12 and 24 months Changes in knee outcome measures (KOOS, IKDC, NRS) 6, 12 and 24 months
Trial Locations
- Locations (12)
Slotervaart Hospital
🇳🇱Amsterdam, Netherlands
Amphia Ziekenhuis
🇳🇱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
Scroll for more (2 remaining)Slotervaart Hospital🇳🇱Amsterdam, Netherlands