NCT02343705

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
3 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

January 16, 2015

Last Update Submit

April 26, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant

    6 Months

  • Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device

    6 Months

Secondary Outcomes (2)

  • Changes in knee outcome measures (KOOS, IKDC, NRS)

    6, 12 and 24 months

  • Device and procedure complication rates

    6, 12 and 24 months

Study Arms (1)

Latella Knee Implant System

EXPERIMENTAL
Device: Latella Knee Implant System

Interventions

Latella Knee Implant SystemDEVICE
Latella Knee Implant System

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of pain due to medial osteoarthritis
  • Qualifying baseline pain scores
  • Kellgren-Lawrence Grades 2-3

You may not qualify if:

  • Osteoporosis
  • Rheumatoid arthritis
  • Joint instability
  • Metal ion allergy
  • Permanent implant in or around the knee joint
  • Prior anterior cruciate ligament reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Slotervaart Hospital

Amsterdam, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

St. Anna Hospital

Geldrop, Netherlands

Location

University Hospital Maastricht

Maastricht, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Fundacion Jimenez Diaz

Madrid, Spain

Location

Royal London Hospital

London, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, United Kingdom

Location

Morriston Hospital

Swansea, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Manoj Ramachandran, MD

    Barts & The London NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

ES(4)GB(3)NL(5)