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出境医 / 临床实验 / Descriptive Study of Multiligamentary Reconstruction of the Knee

Descriptive Study of Multiligamentary Reconstruction of the Knee

Study Description
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
Arms and Interventions
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
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

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
Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Joint mobility of both knees [ Time Frame: 2 years ]
    Postoperative knee function assessed by clinical examination
  • Postoperative laxity in varus, valgus, anterior and posterior drawer [ Time Frame: 2 years ]
    Postoperative knee function assessed by clinical examination
  • Postoperative knee function assessed by scores [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Descriptive Study of Multiligamentary Reconstruction of the Knee
Official Title  ICMJE Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Injury, Knee
Intervention  ICMJE Other: Clinical and radiologic evaluation
Follow up post surgery: clinical and radiologic evaluation
Study Arms  ICMJE Experimental: clinical and radiologic evaluation
Follow up post surgery: clinical and radiologic evaluation
Intervention: Other: Clinical and radiologic evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932838
Other Study ID Numbers  ICMJE P17/12_ Reconstruction
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicolas Pujol, Versailles Hospital
Study Sponsor  ICMJE Versailles Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Versailles Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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