Osteoarthritis
Conditions
Brief summary
The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.
Interventions
Sponsors
Cotera, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months | 6 Months | Mean change in KOOS pain score at 6 months after treatment with the Latella Implant. |
| Primary Safety Endpoint: Surgical re-intervention rate at 6 months | 6 Months | Surgical re-intervention rate during the 6 month period following implantation of the Latella device. |
Secondary
| Measure | Time frame |
|---|---|
| Change in IKDC score | 6, 12 and 24 months |
| Device-related complications rate | 24 months |
| KOOS responder rate based on OARSI-OMERACT criteria | 6, 12 and 24 months |
| Change in KOOS function score | 6, 12 and 24 months |
| Change in KOOS pain score | 12 and 24 months |
| Surgical re-intervention rate | 12 and 24 months |
| Procedure-related complications rate | 24 Months |
| Proportion of subjects reaching MCID in KOOS pain score | 6, 12 and 24 months |
| Change in medial knee pain NRS (while walking) | 6, 12 and 24 months |
Countries
United States
Outcome results
None listed