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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02343705

Enrollment

Registered

2015-01-22

Start date

2015-01-31

Completion date

2017-04-30

Last updated

2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DEVICELatella Knee Implant System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device	6 Months
Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant	6 Months

Secondary

Measure	Time frame
Changes in knee outcome measures (KOOS, IKDC, NRS)	6, 12 and 24 months
Device and procedure complication rates	6, 12 and 24 months

Countries

Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026