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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379308
• Other study ID #: IRBN552024/CHUSTE.
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Thomas NERI, MD PhD
• Phone: (0)477120784
• Email: thomas.neri[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

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)
• datas of medical record
datas of medical record will be collected : epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Surgical complications	Report of surgical complications during the 2 months following the surgery	From surgery to 2 months