A Prospective, Multicenter, Single Arm Feasibility Study... | NCT01982266 | Trialant

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A Prospective, Multicenter, Single Arm Feasibility Study... | NCT01982266 | Trialant

Studies
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip

NCT01982266

Sponsor

Biomimedica, Inc

Status

Terminated

Last Update Posted

May 18, 2016Estimated

Enrollment

4Actual

Phase

Not Applicable

Conditions

Degenerative Joint Disease of the Hip

Interventions

GRADION™ Hip Total Cartilage Replacement (TCR)™

Countries

Netherlands

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

NCT01982266

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

EP052

Secondary IDs

Not provided

Brief Title

A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip

Official Title

A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip

Acronym

Not provided

Organization

Biomimedica, IncINDUSTRY

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Device failure

Expanded Access Info

No

Start Date

Nov 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 6, 2013

First Posted Date

Nov 13, 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

May 16, 2016

Last Update Posted Date

May 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Biomimedica, IncINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.

Detailed Description

Not provided

Conditions Module

Conditions

Degenerative Joint Disease of the Hip

Keywords

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GRADION™ Hip Total Cartilage Replacement (TCR)™	Experimental		Device: GRADION™ Hip Total Cartilage Replacement (TCR)™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GRADION™ Hip Total Cartilage Replacement (TCR)™	Device		GRADION™ Hip Total Cartilage Replacement (TCR)™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement
Skeletally mature or at least 18 years of age and has normal anatomy
Patient signs the Informed Consent form
Failed medical management
There will be size limitations on patients also - available size range is 46mm-54mm.

Exclusion Criteria:

Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components
Previous fusion, acute femoral neck fracture and/or above knee amputation
Revision of any previous hip procedure
Slipped capital femoral epiphysis (SCFE)
Rheumatoid arthritis
AVN

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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
Rijnstate Arnhem		Arnhem		6815	Netherlands

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

N/A

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided