Descriptive Study of the Reconstruction of Osteochondral... | NCT03908931

Studies
Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results

NCT03908931

Sponsor

Versailles Hospital

Status

Recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Osteochondral Defect

Interventions

Countries

France

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 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Apr 1, 2019Actual

Completion Date

Jun 1, 2035Estimated

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Apr 8, 2019

First Posted Date

Apr 9, 2019Actual

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 16, 2026

Last Update Posted Date

Mar 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 purpose of this study is to evaluate the clinical results and MRI imaging of autologous cartilage reconstructions or collagen matrix of the knee.

There is currently little data in the literature on clinical outcomes and imaging of this type of lesion.

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

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI	Experimental		Radiation: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Radiation	Follow up of osteochondral surgery by MRI and clinical examination	MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative knee function assessed by clinical examination		2 years post surgery
Postoperative knee function assessed by scores		2 years post surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cartilaginous reconstruction by autologous transplant or collagenous chondro-inducing knee matrix
> 18 years

Exclusion Criteria:

Other cartilaginous reconstruction techniques,
other than knee joint

Accepts Healthy Volunteers

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

Name	Role	Phone	Extension	Email
Nicolas PUJOL	Contact	+33139639565		npujol@ch-versailles.fr
Laure Morisset	Contact	+33139239785		lmorisset@ch-versailles.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH de Versailles	Recruiting	Le Chesnay			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided