Evaluation of the Latella™ Knee Implant System for Medial... | NCT02608957

Studies
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction

NCT02608957

Sponsor

Cotera, Inc.

Status

Terminated

Last Update Posted

Apr 4, 2017Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Latella Knee Implant System

Countries

United States

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

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor elected to terminate the study prior to subject treatment.

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

May 2016Actual

Completion Date

Mar 2017Actual

First Submitted Date

Nov 13, 2015

First Submission Date that Met QC Criteria

Nov 17, 2015

First Posted Date

Nov 20, 2015Estimated

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

Mar 30, 2017

Last Update Posted Date

Apr 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

1Actual

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

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
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The George Washington University		Washington D.C.	District of Columbia	20037	United States
Rush University Medical Center

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