Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

Cotera

Status: Terminated

Conditions: Osteoarthritis

Treatments: Device: Latella Knee Implant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02343705

CIP-0001

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Latella Knee Implant System

Experimental group

Treatment:

Device: Latella Knee Implant System