Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction
Not Applicable
Terminated
- Conditions
- Osteoarthritis
- Registration Number
- NCT02608957
- Lead Sponsor
- Cotera, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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 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.
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.
- Secondary Outcome Measures
Name Time Method Change in KOOS pain score 12 and 24 months Change in medial knee pain NRS (while walking) 6, 12 and 24 months Device-related complications rate 24 months Surgical re-intervention rate 12 and 24 months Procedure-related complications rate 24 Months Change in KOOS function score 6, 12 and 24 months Change in IKDC score 6, 12 and 24 months Proportion of subjects reaching MCID in KOOS pain score 6, 12 and 24 months KOOS responder rate based on OARSI-OMERACT criteria 6, 12 and 24 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the Latella Knee Implant System's efficacy in medial osteoarthritis pain reduction?
How does the Latella Knee Implant System compare to standard-of-care treatments for medial compartment osteoarthritis in terms of pain relief and functional outcomes?
Are there specific biomarkers that can predict optimal patient selection for the Latella Knee Implant System in treating medial osteoarthritis?
What are the known adverse events associated with the Latella Knee Implant System and how do they compare to other knee implant devices like the PCL-retaining or posterior-stabilized prostheses?
What combination therapies or alternative devices are being explored alongside the Latella Knee Implant System for enhanced treatment of knee osteoarthritis?
Trial Locations
- Locations (2)
The George Washington University
🇺🇸Washington, District of Columbia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The George Washington University🇺🇸Washington, District of Columbia, United States