NCT02002637

Brief Summary

The objective of this study is to evaluate the safety and technical feasibility of implanting the Latella Implant System in the treatment of patients with medial osteoarthritis of the knee.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

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

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.6 years 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

1.8 years

First QC Date

December 2, 2013

Last Update Submit

April 26, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Freedom from unanticipated serious adverse device effects

    12 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 - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of pain as due to medial osteoarthritis

You may not qualify if:

  • Rheumatoid arthritis
  • Joint or ligament instability
  • Metal ion allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Slotervaart Hospital

Amsterdam, Netherlands

Location

Barts Health NHS Trust

London, 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
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 6, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2015

Study Completion

April 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

GB(1)NL(1)