Back to resultsDescriptive Study of Multiligamentary Reconstruction of the Knee
Primary Purpose
Injury, Knee
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical and radiologic evaluation
Sponsored by
About this trial
This is an interventional basic science trial for Injury, Knee
Eligibility 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.
Sites / Locations
- CH de VersaillesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
clinical and radiologic evaluation
Arm Description
Follow up post surgery: clinical and radiologic evaluation
Outcomes
Primary Outcome Measures
Joint mobility of both knees
Postoperative knee function assessed by clinical examination
Postoperative laxity in varus, valgus, anterior and posterior drawer
Postoperative knee function assessed by clinical examination
Postoperative knee function assessed by scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03932838
Brief Title
Descriptive Study of Multiligamentary Reconstruction of the Knee
Official Title
Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury, Knee
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
clinical and radiologic evaluation
Arm Type
Experimental
Arm Description
Follow up post surgery: clinical and radiologic evaluation
Intervention Type
Other
Intervention Name(s)
Clinical and radiologic evaluation
Intervention Description
Follow up post surgery: clinical and radiologic evaluation
Primary Outcome Measure Information:
Title
Joint mobility of both knees
Description
Postoperative knee function assessed by clinical examination
Time Frame
2 years
Title
Postoperative laxity in varus, valgus, anterior and posterior drawer
Description
Postoperative knee function assessed by clinical examination
Time Frame
2 years
Title
Postoperative knee function assessed by scores
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Pujol
Phone
0139639565
Email
npujol@ch-versailles.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Morisset
Phone
0139239785
Email
lmorisset@ch-versailles.fr
Facility Information:
Facility Name
CH de Versailles
City
Le Chesnay
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pujol
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Descriptive Study of Multiligamentary Reconstruction of the Knee
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