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

NCT06379308 | Recruiting

• 1 other identifier: IRBN552024/CHUSTE.
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Knee; ACL; revision; surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Surgical complications

  From surgery to 2 months

Study Arms (1)

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; Other: datas of medical record

Interventions

questionaries OTHER

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)

Patient with Anterior Cruciate Ligament (ACL) revision

datas of medical record OTHER

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

Patient with Anterior Cruciate Ligament (ACL) revision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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".

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Thomas NERI, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas NERI, MD PhD

CONTACT

(0)477120784; thomas.neri@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)