Descriptive Study of Multiligamentary Reconstruction of the Knee

Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.

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.

Study Overview

• Status: Recruiting
• Conditions: Injury, Knee
• Intervention / Treatment: Other: Clinical and radiologic evaluation

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Pujol; Phone Number: 0139639565; Email: npujol@ch-versailles.fr
• Study Contact Backup: Name: Laure Morisset; Phone Number: 0139239785; Email: lmorisset@ch-versailles.fr

Study Locations

• France
  • Le Chesnay, France
    • Recruiting
    • CH de Versailles
    • Contact: Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint mobility of both knees	Postoperative knee function assessed by clinical examination	2 years
Postoperative laxity in varus, valgus, anterior and posterior drawer	Postoperative knee function assessed by clinical examination	2 years
Postoperative knee function assessed by scores		2 years

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Estimated): June 1, 2035

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Physical Phenomena; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; X-Rays
• Other Study ID Numbers: P17/12_ Reconstruction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No