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TerminatedNCT02002637Updated Apr 28, 2017

Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)

An interventional study of Latella Knee Implant System in Osteoarthritis, sponsored by Cotera, Inc.. Terminated at 2 sites in 2 countries. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-28.

Sponsored by Cotera, Inc. · Not applicable, Interventional, and Device feasibility

Why this study was terminated
Sponsor election
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis

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03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 11 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Cotera, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • History of pain as due to medial osteoarthritis

Exclusion criteria

Exclusion Criteria:

  • Rheumatoid arthritis
  • Joint or ligament instability
  • Metal ion allergy
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Latella Knee Implant System

    Device: Latella Knee Implant System

Interventions

  • DeviceLatella Knee Implant System
06

What researchers measure

Primary outcomes

  1. Freedom from unanticipated serious adverse device effects

    Time frame: 12 Months

07

Study locations

2 sites
  • Slotervaart Hospital
    Amsterdam, Netherlands
  • Barts Health NHS Trust
    London, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Sep 2015 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2013
First posted
Dec 6, 2013
Start
Nov 2013
Primary completionActual
Sep 2015
CompletionActual
Apr 2017
Last update
Apr 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02002637
Lead sponsor
Cotera, Inc.
Responsible party
Sponsor
First posted
Dec 6, 2013
Start date
Nov 2013
Primary completion
Sep 2015
Completion
Apr 2017
Last update
Apr 28, 2017

Study contacts

Manoj Ramachandran, MD
principal investigator · Barts & The London NHS Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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