ChonDux for Filling Full Thickness Cartilage Defects in t... | NCT01110070

Studies
ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee

NCT01110070

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Jul 7, 2017Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Cartilage Defect

Interventions

ChonDux
ChonDux

Countries

Austria
Germany
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

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment suspended; follow up continue

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 22, 2010

First Submission Date that Met QC Criteria

Apr 23, 2010

First Posted Date

Apr 26, 2010Estimated

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

Jul 6, 2017

Last Update Posted Date

Jul 7, 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 use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.

Detailed Description

Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ChonDux plus microfracture	Experimental		Device: ChonDux
Microfracture	Active Comparator		Device: ChonDux

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ChonDux	Device	Comparison of ChonDux plus microfracture to microfracture only	ChonDux plus microfracture Microfracture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Defect fill at 6 months determined by magnetic resonance imaging (MRI)		6 months

Secondary Outcomes

Measure	Description	Time Frame
Pain score (VAS)		6 months
Knee function as assessed by the IKDC questionnaire		6 months
SF-36 Health Survey

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A standing radiograph of the knee showing a Kellgren score of 0-2
Body mass index ≤33
An Outerbridge score of III or IV without need for bone graft
A meniscus with no more than partial resection in the affected knee

Exclusion Criteria:

Passive motion deficit of the knee (>5º of extension, >15º of flexion)
Moderate or severe osteoarthritis
Diabetes mellitus (IDDM Type 1)
Patellofemoral instability
Malalignment with > 5° valgus or varus compared to contralateral knee
Active osteomyelitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

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
Medalp		Imst			Austria
Ortho.Abteilung, AKH Linz

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30280586	Derived	Wolf MT, Zhang H, Sharma B, Marcus NA, Pietzner U, Fickert S, Lueth A, Albers GHR, Elisseeff JH. Two-Year Follow-Up and Remodeling Kinetics of ChonDux Hydrogel for Full-Thickness Cartilage Defect Repair in the Knee. Cartilage. 2020 Oct;11(4):447-457. doi: 10.1177/1947603518800547. Epub 2018 Oct 3.

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries