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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908931
Recruitment Status : Unknown
Verified April 2019 by Nicolas Pujol, Versailles Hospital.
Recruitment status was:  Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Nicolas Pujol, Versailles Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteochondral Defect Radiation: MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MRI Radiation: MRI
Follow up of osteochondral surgery by MRI and clinical examination


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative knee function assessed by clinical examination [ Time Frame: 2 years post surgery ]
  2. Postoperative knee function assessed by scores [ Time Frame: 2 years post surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908931


Contacts
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Contact: Nicolas PUJOL +33139639565 npujol@ch-versailles.fr
Contact: Laure Morisset +33139239785 lmorisset@ch-versailles.fr

Locations
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France
CH de Versailles Recruiting
Le Chesnay, France
Contact: Pujol         
Sponsors and Collaborators
Versailles Hospital
More Information
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Responsible Party: Nicolas Pujol, Principal Investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03908931    
Other Study ID Numbers: P19/02
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No