NCT02608957

Brief Summary

The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

November 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

November 13, 2015

Last Update Submit

March 30, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months

    Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.

    6 Months

  • Primary Safety Endpoint: Surgical re-intervention rate at 6 months

    Surgical re-intervention rate during the 6 month period following implantation of the Latella device.

    6 Months

Secondary Outcomes (9)

  • Change in KOOS function score

    6, 12 and 24 months

  • Change in medial knee pain NRS (while walking)

    6, 12 and 24 months

  • Change in IKDC score

    6, 12 and 24 months

  • Device-related complications rate

    24 months

  • KOOS responder rate based on OARSI-OMERACT criteria

    6, 12 and 24 months

  • +4 more secondary outcomes

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 (2)

The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

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

November 13, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2016

Study Completion

March 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(2)