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

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Latella Knee Implant System
Sponsored by
Cotera, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Slotervaart Hospital
  • Amphia Ziekenhuis
  • St. Anna Hospital
  • University Hospital Maastricht
  • Isala
  • Hospital Clinic
  • Hospital Vall d'Hebron
  • Hospital Clinico San Carlos
  • Hospital Fundacion Jimenez Diaz
  • Royal London Hospital
  • Norfolk & Norwich University Hospital
  • Morriston Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Latella Knee Implant System

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in knee outcome measures (KOOS, IKDC, NRS)
Device and procedure complication rates

Full Information

First Posted
January 16, 2015
Last Updated
April 26, 2017
Sponsor
Cotera, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02343705
Brief Title
Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
Official Title
Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor election
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cotera, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latella Knee Implant System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Latella Knee Implant System
Primary Outcome Measure Information:
Title
Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant
Time Frame
6 Months
Title
Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Changes in knee outcome measures (KOOS, IKDC, NRS)
Time Frame
6, 12 and 24 months
Title
Device and procedure complication rates
Time Frame
6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Ramachandran, MD
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Slotervaart Hospital
City
Amsterdam
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
St. Anna Hospital
City
Geldrop
Country
Netherlands
Facility Name
University Hospital Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Isala
City
Zwolle
Country
Netherlands
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Royal London Hospital
City
London
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norwich
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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