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NCT02343705 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02343705
Other study ID # CIP-0001
Secondary ID
Status Terminated
Phase N/A
First received January 16, 2015
Last updated April 26, 2017
Start date January 2015
Est. completion date April 2017

Study information
Verified date April 2017
Source Cotera, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 67
Est. completion date April 2017
Est. primary completion date April 2017
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Latella Knee Implant System

Locations
Country Name City State
Netherlands Slotervaart Hospital Amsterdam
Netherlands Amphia Ziekenhuis Breda
Netherlands St. Anna Hospital Geldrop
Netherlands University Hospital Maastricht Maastricht
Netherlands Isala Zwolle
Spain Hospital Clinic Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Fundacion Jimenez Diaz Madrid
United Kingdom Royal London Hospital London
United Kingdom Norfolk & Norwich University Hospital Norwich
United Kingdom Morriston Hospital Swansea

Sponsors (1)
Lead Sponsor Collaborator
Cotera, Inc.

Countries where clinical trial is conducted

Netherlands,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant 6 Months
Primary Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device 6 Months
Secondary Changes in knee outcome measures (KOOS, IKDC, NRS) 6, 12 and 24 months
Secondary Device and procedure complication rates 6, 12 and 24 months
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