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NCT Number: NCT07765173

Muscle Function Following Anterior Cruciate Ligament Reconstruction: Impaired Power Output in Physically Active Individuals

The goal of this clinical trial is to to determine the extent of the association between objective changes in the muscle function of the knee extensors (strength and power) and the function reported by the patient following ACL reconstruction surgery. The main questions it aims to answer is:

- Pre- and post-operative (6 months) changes in maximum knee extensor strength following ACL reconstruction, correlated with the IKDC-SKF score.

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Key information

Conditions

ACL Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Before surgery :

  • The patient will undergo a series of assessment tests, including:
  • An assessment of the force-velocity and power-velocity relationships for each leg during a cycling task
  • An assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
  • An assessment of maximum strength and explosive strength in isometric (static) mode of the knee extensors.
  • A questionnaire-based assessment of IKDC-SKF scores. Evaluations will be repeated at 3 and 6 month after surgery ; Patients will be monitored for up to 24 months following their surgery

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients requiring isolated or complex ACL reconstruction (combined with a meniscal injury)
  • Patients who are physically active (Tegner score ≥ 4) and wish to resume such activity.
  • Patients with no history of surgery on the ipsilateral knee (i.e., native knee).
  • Patients able to comply with the study procedures
  • Patients who have given their free and informed written consent, having been informed of the purpose of the study, its procedure and its risks.
  • Be affiliated to a social security scheme.

Exclusion criteria

  • Patient with comprehension difficulties
  • Recurrent rupture of the ipsilateral ACL
  • Multi-ligament injuries (i.e., injury to the medial collateral ligament, lateral collateral ligament or posterior cruciate ligament)

Treatment and study plan

Assessment

Other
  • Assessment of force-velocity and power-velocity relationships in each leg during a cycling task
  • Assessment of unilateral force-velocity and power-velocity relationships during a knee extension task
  • Assessment of maximum force and explosive force in isometric (static) conditions of the knee extensors.
  • Measurement of scores using questionnaires (IKDC-SKF).

Primary outcomes

  1. Correlation of maximum knee extension strength to IKDC-SKF scores

    Time frame: 6 month

    Relationship (r coefficient) between 0-6 month delta of maximum knee extension strength measurements and International Knee Documentation Commitee-SKF scores (100: no limitation)

Secondary outcomes

  1. Peri-operatory trajectory of maximal dynamic force

    Time frame: 0, 3 and 6 month

    Trajectory of evolution of F0 (maximal dynamic force) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).

  2. Peri-operatory trajectory of maximal contraction velocity

    Time frame: 0, 3 and 6 month

    Trajectory of evolution of V0 (maximal contraction velocity) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).

  3. Peri-operatory trajectory of rate of force development

    Time frame: 0, 3 and 6 month

    Trajectory of evolution of rate of force development between baseline, 3 and 6 months, compared between legs (linear mixed effect model).

  4. Peri-operatory trajectory of maximal isometric force

    Time frame: 0, 3 and 6 month

    Trajectory of evolution of maximal isometric force (Fmax) between baseline, 3 and 6 months, compared between legs (linear mixed effect model).

  5. Peri-operatory trajectory of maximal dynamic force during cycling

    Time frame: 0, 3 and 6 month

    Trajectory of evolution of maximal dynamic force (F0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).

  6. Peri-operatory trajectory of maximal contraction velocity during cycling

    Time frame: 0, 3 and 6 month

    Trajectory of evolution of maximal contraction velocity (V0) during cycling between baseline, 3 and 6 months (linear mixed effect model, one fixed factor).

  7. Determinants of fonctional prognosis

    Time frame: 0, 3 and 24 month

    Multivariate analysis including the IKDC-SKF score at 24 months as dependant variable and, as predictors :

    • the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
    • the severity of the lesion (presence of associated lesions)
    • the presence of a pre-operatory rehabilitation.

  8. Determinants of fonctional prognosis

    Time frame: 0, 3 and 24 month

    Multivariate analysis including the recurrence of ACL lesion at 24 months (0/1) as dependant variable and, as predictors :

    • the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
    • the severity of the lesion (presence of associated lesions)
    • the presence of a pre-operatory rehabilitation.

  9. Determinants of fonctional prognosis

    Time frame: 0, 3 and 24 month

    Multivariate analysis including resuming physical activity at the pre-injury level at 24 months (0/1) as dependant variable and, as predictors :

    • the 0-3 month delta of V0, F0, RFD and Fmax during knee extension on the operated leg.
    • the severity of the lesion (presence of associated lesions)
    • the presence of a pre-operatory rehabilitation.

Study contacts

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

leo blervaque

CONTACT

[email protected]

04.79.96.58.13

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Collaborators

  • Université Savoie Mont Blanc

Registry information

Acronym: ReGAIN

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

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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