Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction

Osteoarthritis Clinical Trial

— Latella-US  

Official title:

Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02608957
• Other study ID #: CIP-0002
• Status: Terminated
• Phase: N/A
• First received: November 13, 2015
• Last updated: March 30, 2017
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Cotera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Latella Knee Implant System

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	The George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cotera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months	Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.	6 Months
Primary	Primary Safety Endpoint: Surgical re-intervention rate at 6 months	Surgical re-intervention rate during the 6 month period following implantation of the Latella device.	6 Months
Secondary	Change in KOOS function score		6, 12 and 24 months
Secondary	Change in medial knee pain NRS (while walking)		6, 12 and 24 months
Secondary	Change in IKDC score		6, 12 and 24 months
Secondary	Device-related complications rate		24 months
Secondary	KOOS responder rate based on OARSI-OMERACT criteria		6, 12 and 24 months
Secondary	Proportion of subjects reaching MCID in KOOS pain score		6, 12 and 24 months
Secondary	Change in KOOS pain score		12 and 24 months
Secondary	Surgical re-intervention rate		12 and 24 months
Secondary	Procedure-related complications rate		24 Months