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Descriptive Study of Multiligamentary Reconstruction of the Knee

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: NCT03932838
Recruitment Status : Unknown
Verified April 2019 by Nicolas Pujol, Versailles Hospital.
Recruitment status was:  Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Nicolas Pujol, Versailles Hospital

Study Description
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Brief Summary:

Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.

There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.


Condition or disease Intervention/treatment Phase
Injury, Knee Other: Clinical and radiologic evaluation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2019
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: clinical and radiologic evaluation
Follow up post surgery: clinical and radiologic evaluation
 Other: Clinical and radiologic evaluation
Follow up post surgery: clinical and radiologic evaluation


Outcome Measures
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Primary Outcome Measures :
  1. Joint mobility of both knees [ Time Frame: 2 years ]
    Postoperative knee function assessed by clinical examination

  2. Postoperative laxity in varus, valgus, anterior and posterior drawer [ Time Frame: 2 years ]
    Postoperative knee function assessed by clinical examination

  3. Postoperative knee function assessed by scores [ Time Frame: 2 years ]

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:

  • Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury
  • >18 years old

Exclusion Criteria:

  • Neurological or vascular injury during trauma.
  • Fracture of the femur or both bones of the leg.
  • Ligamentous lesion on the contralateral knee.
  • History of surgery on the affected knee.
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): NCT03932838


Contacts
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Contact: Nicolas Pujol 0139639565 npujol@ch-versailles.fr
Contact: Laure Morisset 0139239785 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 Investigateur, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03932838    
Other Study ID Numbers: P17/12_ Reconstruction
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 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
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries