Feasibility of the Latella Implant System for Medial Oste... | NCT02002637

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

NCT02002637

Sponsor

Cotera, Inc.

Status

Terminated

Last Update Posted

Apr 28, 2017Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Latella Knee Implant System

Countries

Netherlands
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
COTERA-1

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor election

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Sep 2015Actual

Completion Date

Apr 2017Actual

First Submitted Date

Dec 2, 2013

First Submission Date that Met QC Criteria

Dec 5, 2013

First Posted Date

Dec 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2017

Last Update Posted Date

Apr 28, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Latella Knee Implant System	Experimental		Device: Latella Knee Implant System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latella Knee Implant System	Device		Latella Knee Implant System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom from unanticipated serious adverse device effects		12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of pain as due to medial osteoarthritis

Exclusion Criteria:

Rheumatoid arthritis
Joint or ligament instability
Metal ion allergy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manoj Ramachandran, MD	Barts & The London NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Slotervaart Hospital		Amsterdam			Netherlands
Barts Health NHS Trust

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided