Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study

This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Other: questionaries; Other: datas of medical record

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Thomas NERI, MD PhD; Phone Number: +33 (0)477120784; Email: thomas.neri@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • Recruiting
    • CHU Saint-Etienne
    • Principal Investigator: Thomas NERI, MD PhD
    • Contact: Thomas NERI, MD PhD; Phone Number: +33 (0)477120784; Email: thomas.neri@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with an anterior cruciate ligament (ACL) revision will be included.

Description

Inclusion Criteria:

• Patient with an anterior cruciate ligament (ACL) revision, defined as "all surgical procedures involving replacement of the anterior cruciate ligament (ACL) graft with a new graft".

Exclusion Criteria:

• multil-igament injuries
• any procedure where the ACL was not revised and where any additional graft was inserted
• Patients who had already undergone their first revision anterior cruciate ligament (ACL) procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patient with Anterior Cruciate Ligament (ACL) revision; Patient with Anterior Cruciate Ligament (ACL) revision will be included. Questionary will be administrated and datas will be collected by medical record.

Other: questionaries; Questionaries will be administered : Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI); Tegner Activity Scale (TAS); Simple Knee Value (SKV); International Knee Documentation Commitee (IKDC); Other: datas of medical record; datas of medical record will be collected : epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)	Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) will be analyzed. questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) has 12 questions (min = 0, max = 100). Greater psychological preparation is indicated by higher scores.	Months: 0, 6, 12 and 24
Results of Functional score questionary Tegner Activity Scale (TAS)	Results of Functional score questionary Tegner Activity Scale (TAS) will be analyzed. The Tegner Activity Scale (TAS) is a scale of sporting and professional physical activities: from 0 (professional disability due to knee) to 10 (competitive sport such as soccer or rugby at national or international level).	Months: 0, 6, 12 and 24
Results of Functional score questionary Simple Knee Value (SKV)	Results of Functional score questionary Simple Knee Value (SKV) will be analyzed. Scale from 0 to 100 to evaluate the knee function in daily life (0 is no function and 100 is normal function)	Months: 0, 6, 12 and 24
Results of Functional score questionary International Knee Documentation Commitee (IKDC)	Results of Functional score questionary Knee Documentation Commitee (IKDC) will be analyzed. Subjective evaluation of the knee function (from 0 to 100%, 0 is no function and 100 is normal function)	Months: 0, 6, 12 and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Report of surgical complications during the 2 months following the surgery	From surgery to 2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Thomas NERI, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ACL; surgery; Knee; revision
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: IRBN552024/CHUSTE.

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