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NCT Number: NCT06379308

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).

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Location status: Recruiting

Location contact

Thomas NERI, MD PhD

CONTACT

[email protected]

(0)477120784 ext. +33

Thomas NERI, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Primary outcomes

  1. Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)

    Time frame: Months: 0, 6, 12 and 24

    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.

  2. Results of Functional score questionary Tegner Activity Scale (TAS)

    Time frame: Months: 0, 6, 12 and 24

    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).

  3. Results of Functional score questionary Simple Knee Value (SKV)

    Time frame: Months: 0, 6, 12 and 24

    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)

  4. Results of Functional score questionary International Knee Documentation Commitee (IKDC)

    Time frame: Months: 0, 6, 12 and 24

    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)

Secondary outcomes

  1. Surgical complications

    Time frame: From surgery to 2 months

    Report of surgical complications during the 2 months following the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas NERI, MD PhD

CONTACT

[email protected]

(0)477120784 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Apr 23, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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